#Heater-cooler units used during cardiac surgery

[octopusmedical01]

Sorin Stockert 3T Heater-Cooling System manufacturer & supplier in India: Octopus Med Pvt Ltd. 

In the realm of medical technology, innovations play a pivotal role in enhancing patient care and outcomes. Among the many advancements, the Sorin Stockert 3T Heater-Cooler System stands out as a crucial component in cardiac surgeries, ensuring optimal temperature management during procedures. As a trusted manufacturer and supplier of Sorin Stockert 3T Heater-Cooler System in India, Octopus Med brings you the Sorin Stockert 3T Heater-Cooler System, delivering unparalleled performance and reliability. 

About the Sorin Stockert 3T Heater-Cooler System 

The Sorin Stockert 3T Heater-Cooler System is a sophisticated medical device designed to regulate the temperature of patient's blood and organs during cardiac surgeries. It consists of advanced heating and cooling components that maintain precise temperatures, critical for the success of complex procedures. Octopus Med offers the Sorin 3T Heater Cooler Systems, recognized for their superior quality and performance in the medical community. 

Key Features of Sorin Stockert 3T Heater-Cooler System: 

Precision Temperature Control: The Sorin Stockert 3T Heater-Cooler System ensures precise temperature management, allowing surgeons to maintain optimal conditions throughout the surgical procedure. 

Reliable Performance: With its robust design and advanced technology, the Sorin 3T Heater Cooler guarantees reliable performance, contributing to seamless surgical experiences and positive patient outcomes. 

Enhanced Safety Features: Sorin Stockert 3T Heater-Cooler Systems are equipped with enhanced safety features to mitigate risks and ensure patient safety during cardiac surgeries. 

User-Friendly Interface: The intuitive interface of the Sorin Stockert 3T Heater-Cooler System facilitates ease of use for healthcare professionals, enabling efficient operation and monitoring during procedures. 

Buy SORIN Stockert 3T at Best Price in India 

Octopus Med offers the Sorin Stockert 3T Heater-Cooler System at the best price in India, making advanced medical technology accessible to healthcare facilities nationwide. Our commitment to affordability and quality ensures that healthcare providers can procure essential equipment without compromising on performance or budget. 

Why Choose Octopus Med for Sorin Stockert 3T Heater-Cooler System? 

Quality Assurance: Octopus Med is dedicated to delivering products of the highest quality, backed by rigorous quality assurance processes and adherence to international standards. 

Expertise and Experience: With years of experience in the healthcare industry, Octopus Med has established itself as a trusted name, offering innovative solutions and unparalleled customer service. 

Customer Satisfaction: At Octopus Med, customer satisfaction is paramount. We strive to exceed expectations by providing timely support, seamless transactions, and personalized service to our clients. 

Nationwide Reach: Octopus Med's extensive distribution network ensures prompt delivery of Sorin Stockert 3T Heater-Cooler Systems to healthcare facilities across India, enabling timely access to essential medical equipment. 

In conclusion, the Sorin Stockert 3T Heater-Cooler System from Octopus Med India represents a paradigm shift in cardiac surgery technology, empowering healthcare providers to deliver superior patient care. With its advanced features, reliability, and affordability, the Sorin Stockert 3T Heater-Cooler System is a valuable addition to any cardiac surgery suite. Contact Octopus Med today to buy SORIN Stockert 3T at the best price in India and elevate your surgical capabilities to new heights. 

[octopusmedical]

Octopus Medical: Medical equipment supplier company in India 

Octopus Medical is a prominent medical equipment supplier company in India, specializing in providing a comprehensive range of high-quality medical devices and equipment to healthcare facilities across the country. With a commitment to excellence, reliability, and innovation, Octopus Medical serves as a trusted partner for hospitals, clinics, diagnostic centers, and other healthcare providers, offering a diverse portfolio of products to meet their clinical needs.

As a leading medical equipment supplier, Octopus Medical offers a wide range of products, including: 

Ventilators: Advanced respiratory support systems for patients requiring mechanical ventilation. 

Anesthesia Machines: Precision anesthesia delivery systems for surgical procedures and patient care. 

Surgical Microscopes: High-quality optical devices for magnified visualization during surgical interventions. 

Coagulation Analyzers: Laboratory instruments for analyzing blood clotting parameters and coagulation profiles. 

Electro-Surgical Units: Surgical devices used for cutting, coagulating, and dissecting tissue during surgical procedures. 

Defibrillators: Life-saving devices for delivering electrical shocks to restore normal heart rhythm in cardiac arrest patients. 

Dopplers: Diagnostic devices for assessing blood flow velocity and detecting vascular abnormalities. 

Heater-Cooler Systems: Temperature management devices used during surgical procedures to regulate patient body temperature. 

Intra-Aortic Balloon Pumps: Hemodynamic support systems for patients with heart failure or undergoing cardiac surgery. 

Octopus Medical is known for its commitment to quality, reliability, and customer satisfaction. The company ensures that all products meet stringent quality standards and regulatory requirements, providing healthcare facilities with peace of mind and confidence in their equipment. Additionally, Octopus Medical offers comprehensive customer support and after-sales service, including installation, training, maintenance, and technical assistance, to ensure optimal performance and functionality of its products. 

Overall, Octopus Medical is a trusted medical equipment supplier company in India, dedicated to supporting healthcare providers with innovative and reliable solutions to enhance patient care and outcomes. 

[lindamcsherry]

Heart Surgery Infection Settlement Results in $225M Payment Over 3T Heater Cooler Contamination

Livanova has agreed to pay $225 million to settle most heart surgery infection lawsuits filed over problems with 3T Heater-Cooler systems commonly used in recent years during cardiac procedures, which were contaminated and caused devastating infections that could surface months or years later.

The manufacturer issued a press release on March 29, announcing that it had reached an agreement to resolve about 75% of the pending cases filed nationwide in recent years. The settlement involves a total payment of up to $225 million, with $135 million paid no earlier than July 2019, and the rest paid in January 2020.

It is unclear how many cases are resolved in the deal, but there are currently at least 85 product liability lawsuits pending in the federal court system, which are centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, as part of an MDL, or multidistrict litigation.

Each of the complaints filed in recent years raise similar allegations, indicating that certain 3T Heater-Cooler Systems were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious and life-threatening infections following heart surgery.

Livanova notes that it had established a reserve of $294 million in the fourth quarter to pay for the ongoing 3T Heater Cooler litigation.

“We believe entering into the settlement is in the best interest of the Company, its shareholders and patients, because it will remove ongoing costs and uncertainty as we focus on executing our strategy to deliver quality care to patients around the world,” Damien McDonald, Chief Executive Officer of LivaNova, said in the press release.

The agreement does not include an admission of guilt by Livanova.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler designed to help regulate blood temperature. However, concerns over the safety of the devices emerged in late 2015, when the FDA warned about reports of heart surgery infections linked to heater-coolers, indicating that a large number of adverse event reports had been received by the agency.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Heart Surgery Infection Settlement Results in $225M Payment Over 3T Heater Cooler Contamination appeared first on AboutLawsuits.com.

[cassandradodds]

Lawsuits Filed over LivaNova Stöckert 3T Heater-Cooler Infections

LivaNova Sued Over NTM Infections from Heater-Cooler Devices

LivaNova, formerly known as Sorin Group, has been facing contamination concerns associated with its Stöckert 3T Heater-Cooler Devices for several years. Now, the company is facing lawsuits alleging that their heater-cooler devices caused nontuberculous mycobacterium (NTM) infections in patients undergoing open-heart surgery. Regulators, including the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), have warned about this risk.

Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a LivaNova (formerly known as Sorin Group) Stöckert 3T heater-cooler device lawsuit.

Heater-cooler devices are used during surgery to maintain a patient’s body temperature. The system contains a closed water circuit, which does not contact the patient. However, bacteria living in the water circuit can contaminate the sterile environment of the operating room through the exhaust vent. Many patients affected by this issue suffered an infection caused by a type of NTM called Mycobacterium chimaera (M. Chimaera). Symptoms of NTM infection include an unexplained fever, night sweats, fatigue, joint or muscle pain, nausea, difficulty breathing and redness, heat or pus at the surgical incision site.

LivaNova is facing a growing number of lawsuits alleging NTM infections from Stöckert 3T heater-cooler system. Plaintiffs are generally people who underwent heart surgery with the machines; some sued after receiving letters from hospitals warning them of a possible infection. NTM infections are slow-growing, and hard to treat. Patients may not know they have an infection until months or even years after the surgery. According to court records, one woman filed a wrongful death claim on behalf of her deceased husband, who underwent a cardiac bypass procedure in March 2014.

Both individual personal injury lawsuits and class action lawsuits have been filed. A class action lawsuit represents an entire group of plaintiffs.

Stöckert 3T Heater-Cooler Infection Background

The Stöckert 3T heater-cooler device was approved in 2006. Sorin Group, which has since merged with another company to become LivaNova, initially developed the 3T. The 3T heater-cooler system contains three separate tanks of water used to regulate devices that ultimately maintain a patient’s blood and body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries.

According to the FDA, heater-cooler devices can spread NTM infections when the bacteria are aerosolized, or transmitted through the air. The agency received 32 reports of M. chimaera infections associated with 3T heater-cooler devices between 2010 and 2015. In nearly half these patients, the infections were fatal.

Normal, healthy individuals are usually not affected by NTM. The bacteria are normally present in our environment. However, the consequences can be serious in open-heart surgery patients, who are susceptible to illness. When the bacteria aerosolize, they can contaminate sterile equipment, medical devices, or enter the patient’s open chest directly.

Parker Waichman notes that heater-cooler devices have been linked to NTM infections for several years.

In November 2016, the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America, published a study linking the devices to NTM infections.

The lead author of the study is Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” Dr. Sommerstein said. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”

“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,”

The manufacturer discovered M. chimaera contamination on the production line and water supply at the heater-cooler facility in August 2014. That September, the company added cleaning and disinfection procedures on the production line to address the contamination.

The FDA issued a Safety Communication update in October 2016 regarding 3T heater-cooler systems. Regulators issued guidelines to help prevent NTM infections from spreading. Among other things, the FDA said to isolate and remove any contaminated devices from health care facilities. When using a different heater-cooler system, new equipment should be used in conjunction with it. The FDA also said that the heater-cooler exhaust should be directed away from the patient and towards the operating room exhaust vent.

At around the same time, the Centers for Disease Control and Prevention (CDC) also issued a health advisory “advising hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing.”

In Spring of 2015, contaminated heater-cooler devices were linked to NTM infections in six Swiss patients. That July, a Pennsylvania hospital also identified a group of infected patients. The CDC helped conduct an investigation linking the infections to contaminated heater-cooler systems. Using whole-genome sequencing, researchers at the CDC and National Jewish Health found that the NTM infections in the patients and devices were highly related. “This evidence for likely point-source contamination of the 3T heater-cooler devices is consistent with recent reports from Europe that describe matching of M. chimaera sequences from environmental isolates at the device production site in Germany and isolates from patients and devices in Europe,” the CDC said in its health advisory.

Each year in the United States, heater-cooler devices are used in over 250,000 heart bypass procedures. The CDC says LivaNova’s 3T heater-cooler linked to the infections accounts for about 60 percent of all heater-cooler systems in the country.

Filing a Stöckert 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) Stöckert 3T heater-cooler device, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Stöckert 3T heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-filed-livanova-stockert-3t-heater-cooler-infections/

from WordPress https://parkerwaichman.wordpress.com/2017/05/05/lawsuits-filed-over-livanova-stockert-3t-heater-cooler-infections/

[parkerwaichmanlaw]

Lawsuits Filed over LivaNova Stöckert 3T Heater-Cooler Infections

LivaNova Sued Over NTM Infections from Heater-Cooler Devices

LivaNova, formerly known as Sorin Group, has been facing contamination concerns associated with its Stöckert 3T Heater-Cooler Devices for several years. Now, the company is facing lawsuits alleging that their heater-cooler devices caused nontuberculous mycobacterium (NTM) infections in patients undergoing open-heart surgery. Regulators, including the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), have warned about this risk.

Parker Waichman LLP is a national law firm with decades of experience representing clients in medical device injury lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a LivaNova (formerly known as Sorin Group) Stöckert 3T heater-cooler device lawsuit.

Heater-cooler devices are used during surgery to maintain a patient’s body temperature. The system contains a closed water circuit, which does not contact the patient. However, bacteria living in the water circuit can contaminate the sterile environment of the operating room through the exhaust vent. Many patients affected by this issue suffered an infection caused by a type of NTM called Mycobacterium chimaera (M. Chimaera). Symptoms of NTM infection include an unexplained fever, night sweats, fatigue, joint or muscle pain, nausea, difficulty breathing and redness, heat or pus at the surgical incision site.

LivaNova is facing a growing number of lawsuits alleging NTM infections from Stöckert 3T heater-cooler system. Plaintiffs are generally people who underwent heart surgery with the machines; some sued after receiving letters from hospitals warning them of a possible infection. NTM infections are slow-growing, and hard to treat. Patients may not know they have an infection until months or even years after the surgery. According to court records, one woman filed a wrongful death claim on behalf of her deceased husband, who underwent a cardiac bypass procedure in March 2014.

Both individual personal injury lawsuits and class action lawsuits have been filed. A class action lawsuit represents an entire group of plaintiffs.

Stöckert 3T Heater-Cooler Infection Background

The Stöckert 3T heater-cooler device was approved in 2006. Sorin Group, which has since merged with another company to become LivaNova, initially developed the 3T. The 3T heater-cooler system contains three separate tanks of water used to regulate devices that ultimately maintain a patient’s blood and body temperature. The device is used in surgeries where the heart and blood flow is stopped, such as heart transplant surgeries and cardiac bypass surgeries.

According to the FDA, heater-cooler devices can spread NTM infections when the bacteria are aerosolized, or transmitted through the air. The agency received 32 reports of M. chimaera infections associated with 3T heater-cooler devices between 2010 and 2015. In nearly half these patients, the infections were fatal.

Normal, healthy individuals are usually not affected by NTM. The bacteria are normally present in our environment. However, the consequences can be serious in open-heart surgery patients, who are susceptible to illness. When the bacteria aerosolize, they can contaminate sterile equipment, medical devices, or enter the patient’s open chest directly.

Parker Waichman notes that heater-cooler devices have been linked to NTM infections for several years.

In November 2016, the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America, published a study linking the devices to NTM infections.

The lead author of the study is Rami Sommerstein, MD, of Inselspital, Bern University Hospital in Switzerland. “It is surprising that a global outbreak like this could go unnoticed for years. This dangerous infection has put many patients at risk all over the world,” Dr. Sommerstein said. “Now that we know HCDs are the source, individual action from the different players (healthcare institutions, manufacturers, etc.) is needed to contain the ongoing patient risk. The most important action a hospital can take is to remove contaminated HCDs from the operating room and other critical areas. That is the only way to ensure that patients are protected from this infection moving forward.”

“While our understanding of the causes and the extent of the M. chimaera outbreak is growing, several aspects of patient management, device handling and risk mitigation still require clarification,”

The manufacturer discovered M. chimaera contamination on the production line and water supply at the heater-cooler facility in August 2014. That September, the company added cleaning and disinfection procedures on the production line to address the contamination.

The FDA issued a Safety Communication update in October 2016 regarding 3T heater-cooler systems. Regulators issued guidelines to help prevent NTM infections from spreading. Among other things, the FDA said to isolate and remove any contaminated devices from health care facilities. When using a different heater-cooler system, new equipment should be used in conjunction with it. The FDA also said that the heater-cooler exhaust should be directed away from the patient and towards the operating room exhaust vent.

At around the same time, the Centers for Disease Control and Prevention (CDC) also issued a health advisory “advising hospitals to notify patients who underwent open-heart (open-chest) surgery involving a Stöckert 3T heater-cooler that the device was potentially contaminated, possibly putting patients at risk for a life threatening infection. New information indicates that these devices, manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH), were likely contaminated with the rare bacteria Mycobacterium chimaera during manufacturing.”

In Spring of 2015, contaminated heater-cooler devices were linked to NTM infections in six Swiss patients. That July, a Pennsylvania hospital also identified a group of infected patients. The CDC helped conduct an investigation linking the infections to contaminated heater-cooler systems. Using whole-genome sequencing, researchers at the CDC and National Jewish Health found that the NTM infections in the patients and devices were highly related. “This evidence for likely point-source contamination of the 3T heater-cooler devices is consistent with recent reports from Europe that describe matching of M. chimaera sequences from environmental isolates at the device production site in Germany and isolates from patients and devices in Europe,” the CDC said in its health advisory.

Each year in the United States, heater-cooler devices are used in over 250,000 heart bypass procedures. The CDC says LivaNova’s 3T heater-cooler linked to the infections accounts for about 60 percent of all heater-cooler systems in the country.

Filing a Stöckert 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a LivaNova (formerly Sorin Group) Stöckert 3T heater-cooler device, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Stöckert 3T heater-cooler lawsuit, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-filed-livanova-stockert-3t-heater-cooler-infections/

[lindamcsherry]

Heart Surgery Infection Settlements To Be Discussed in Litigation Over 3T Heater-Coolers

The U.S. District Judge overseeing all 3T Heater Cooler System heart infection lawsuits filed in federal courts nationwide has appointed a settlement master to oversee ongoing negotiations aimed at resolving the litigation, avoiding the need for dozens of individual cases to go before juries nationwide. 

There are currently at least 85 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the surgical devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery, which has allegedly caused plaintiffs to develop serious infections that may not surface until months, or even years, after the procedure.

Given similar questions of fact and law presented in the cases, the claims have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

As product liability lawyers continue to review and file complaints for individuals who developed nontuberculous mycobacterim (NTM) infections following exposure to contaminated 3T Heater-Coolers used during open heart surgery, it is ultimately expected that there may be several hundred cases involved in the litigation.

In a case management order (PDF) filed on December 3, Judge Jones appointed Randi Ellis to work as a special master in the litigation, to explore possible heart surgery infection settlements. The order requires the parties to meet and confer on a monthly basis with Ellis to work toward a settlement agreement, and Ellis will report any progress back to the Court.

The order notes that Ellis is a member of the Academy of Court Appointed Special Masters, and has served in that capacity in numerous federal and state cases. Plaintiffs and defendants have been ordered to split her fees evenly.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler is a medical device commonly used during cardiac surgery and other procedures to help regulate blood temperature. However, litigation over the heater-coolers emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Heart Surgery Infection Settlements To Be Discussed in Litigation Over 3T Heater-Coolers appeared first on AboutLawsuits.com.

[lindamcsherry]

Heart Transplant NTM Infection Lawsuit Filed Against Makers of 3T Heater-Cooler System

A wrongful death lawsuit recently filed by the widow of a Texas man indicates that a contaminated 3T Heater Cooler System caused a nontuberculous mycobacteria (NTM) infection to develop following heart transplant surgery. 

The complaint (PDF) was filed by Benji Nelson in the U.S. District Court for the Northern District of Texas on October 30, indicating that the widely used heart surgery device increased the risk for complications and infections, which may develop weeks to years later.

Nelson brings the claim on behalf of herself and the estate of her late husband, Terry Nelson, who allegedly was expected to a contaminated 3T Heater-Cooler during a heart transplant in May 2016. The device was used to regulate the temperature of his blood during the procedure, but during the weeks after the surgery he required treatment for crypto pneumonia, recurrent crypto meningitis, nocardia pneumonia and atypiccal mycobacterial infection in the lung.

In September 2016. Terry Nelson was hospitalized and diagnosed with a nontuberculous mycobacteria (NTM) infection. After experiencing acute respiratory failure and other health issues, Nelson was hospitalized again in January 2017 and ultimately died on February 27, 2017, after suffering multi-organ.

Sorin 3T Heater-Coolers are often used during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 were be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.

For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure, all of which are forms of NTM infections like the one that killed Nelson.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

“Defendants knew prior to 2015, and continue to know, that its disclosures to the FDA, the public, and Plaintiff were, and are, incomplete and misleading and that the Sorin 3T System was and is causing numerous patients severe injuries and complications, which violates Federal and State requirements,” Nelson’s lawsuit states. “Defendants suppressed this information and failed to accurately and completely disseminate or share this and other critical information with the FDA, the medical community, health care providers, and patients.”

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

The post Heart Transplant NTM Infection Lawsuit Filed Against Makers of 3T Heater-Cooler System appeared first on AboutLawsuits.com.

[lindamcsherry]

Livanova Issues New 3T Heater-Cooler Cleaning Instructions Due to Heart Surgery Infection Risk

Following reports of heart surgery infections linked to contaminated 3T Heater-Coolers in recent years, the manufacturers indicate the blood temperature regulating machines will be redesigned, and new cleaning instructions have been issued for hospitals that are designed to reduce the risk of infections.

Livanova issued a medical device correction letter (PDF) on October 18, providing customers with updated instructions on the monitoring and use of hydrogen peroxide in the 3T heater Coolers to help prevent microbial growth.

The company also announced that it is making changes to the devices’ vacuum canister and internal sealing to prevent the risk of water vapor being emitted as an aerosol into the operating room, which has been identified as a cause of severe and life-threatening infections that may surface months, or even years, after open heart surgeries where the heater-cooler systems were used.

The FDA also issued a safety communication late last week, passing on the Livanova information and indicating that the agency is staying actively involved with the manufacturer.

The U.S. Centers for Disease Control and Prevention (CDC) is also evaluating Livanova’s infection mitigation efforts and conducting its own scientific research, according to the FDA statement, which indicates that the CDC will issue further updates as appropriate.

Sorin 3T Heater-Coolers are commonly found in operating rooms to regulate blood temperature during heart bypass surgery, valve replacement surgery and other cardiac procedures. However, in recent years it has been discovered that certain devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which may be enter the sterile operating room through vapors released by the devices.

For individuals with compromised immune systems and an open chest cavity during heart surgery, this has resulted in reports of Mycobacterium chimaera or Mycobacterium abscessus infections that surface long after the procedure.

The FDA first warned about the heart surgery infection risk from heater-cooler devices in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Later that year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.

“Although the water in the 3T heater-cooler unit does not come into direct contact with the patient, users should be mindful that aerosols are emitted when the 3T is used, primarily during the patient warming phase and at the end of a procedure, when water is returned to the tanks,” Livanova states in the medical device correction letter. “Depending on the characteristics of the bacteria and the concentration of bacteria in the water in the tanks, these aerosols may carry bacteria into the operating room environment. Another risk of contamination for the patient is a direct contact transfer of water/solution droplets containing water-borne, pathogenic microorganisms into the surgical field.”

The letter indicates that users should monitor the hydrogen peroxide concentration in the water solution daily to ensure that there is enough present to fight microbial contamination. The concentration should always remain about 100 parts per million, the letter indicates. It also includes an attachment that has monitoring instructions.

The letter also notes that the company has developed a vacuum canister and internal sealing design change which cuts down on the risk of airborne transmission of NTM. However, it notes that the change would not eliminate the threat entirely.

Customers will be contacted by a company representative to plan the upgrade of affected products.

Livanova faces a growing number of open heart surgery infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.

The post Livanova Issues New 3T Heater-Cooler Cleaning Instructions Due to Heart Surgery Infection Risk appeared first on AboutLawsuits.com.

[lindamcsherry]

Parents Bring Lawsuit Over Child’s Surgical Infection from 3T Heater Cooler

A Louisiana couple indicates that their minor daughter contracted a serious hospital infection due to a contaminated 3T Heater Cooler system used during open heart surgery. 

In a complaint (PDF) filed last week in the U.S. District Court for the Eastern District of Louisiana, Amando Cuellar and Aleyda Romero indicate that tainted systems used to control blood temperature during cardiac surgery exposed their daughter to bacteria which has been linked to reports of similar infections that may surface months or even years later.

The minor child, Valentina Cuellar, underwent open heart surgery in August and September of 2017, at which time a 3T Heater-Cooler was used. Following the procedures, she contracted, and was treated for, mycobacterium abscessus and staphylococcus aureus infections.

According to allegations raised in the lawsuit, Livanova knew for several years about the risk of contamination with it’s 3T Heater-Cooler systems, but failed to provide adequate warnings or take effective actions to address the problem.

“Upon information and belief, by April 2015, [the manufacturer] knew that their ‘enhanced hygiene concept’ was ineffective in eliminating all bacteria, including mycobacteria chimaera, from devices that were not new and/or were already contaminated,” according to the complaint.

The Cuellars raise allegations similar to those presented in dozens of other surgical infection lawsuits filed by individuals nationwide, which claim that devices release contaminated bacteria in a mist into the air of the operating room, which may enter the open surgical wound.

Valentina Cuellar was one of several children diagnosed with infections at the Louisiana Children’s Medical Center, after undergoing heart surgery involving the 3T Heater-Cooler system, according to the lawsuit.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Given similar questions of fact and law presented in lawsuits filed nationwide, the dozens of cases filed throughout the federal court system have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

The post Parents Bring Lawsuit Over Child’s Surgical Infection from 3T Heater Cooler appeared first on AboutLawsuits.com.

[lindamcsherry]

Sternal Infection Lawsuit Filed Over Contaminated Heater-Cooler Used During Pediatric Cardiac Surgery

The mother of a young girl who suffered a nontuberculosis mycobacteria (NTM) infection following heart surgery alleges that the sternal infection was caused by a contaminated 3T Heater-Cooler system used during the procedure. 

Magaley De La Cruz filed a complaint (PDF) against Sorin Group and Liva Nova PLC in the U.S. District Court for the Eastern District of Louisiana on June 25, on behalf of herself and her minor daughter, Genesis De La Cruz.

According to the lawsuit, Genesis underwent a bilateral branch pulmonary arterioplasty procedure in June 2017, at Children’s Hospital in New Orleans. During the procedure, a 3T heater cooler system was used to regulate the temperature of her blood, which the lawsuit resulted in her developing a sternal infection.

In August 2017, De La Cruz and her daughter told a pediatric cardiologist that Genesis was suffering pain, swelling and tenderness around her incision site. She was diagnosed with a NTM sternal wound infection and placed in the children’s intensive care unit (CICU).

“Cultures returned with positive findings of an m. abscessus infection and a rigorous course of antibiotics were instituted, including Zyvox, Zithromax, and Amikacin,” the lawsuit states. “Moreover, wound vac was placed on August 13th and a peripheral IV was placed on August 17th. On or about August 29th, a left internal jugular broviac central line catheter was placed due to the need for long-term IV access.”

Genesis was hospitalized from August 10, 2017, until October 10, 2017. Once she was released she still had to undergo an antibiotic regimen until early March 2018, the lawsuit states.

The claim is one of a growing number of 3T Heater Cooler lawsuits filed in federal courts nationwide, each raising similar allegations that units shipped worldwide were contaminated with NTM bacteria, resulting in patient infections.

3T Heater Cooler Infection Risks

Litigation over the Sorin 3T Heater-Cooler systems has emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Sternal Infection Lawsuit Filed Over Contaminated Heater-Cooler Used During Pediatric Cardiac Surgery appeared first on AboutLawsuits.com.

[lindamcsherry]

Case Management Plan for 3T Heater-Cooler Infection Cases Proposed in MDL

Parties involved in the federal heart surgery infection lawsuits over 3T Heater-Cooler Systems have proposed a case management plan, which would guide the litigation for the next several months. 

There are currently at least 56 product liability lawsuits filed against the manufacturers of the Sorin 3T Heater-Cooler in the federal court system, each raising similar allegations that the devices were contaminated, releasing a mist into the air of operating rooms during open heart surgery that resulted in the development of serious infections that often do not surface until months, or even years, after the procedure.

Given similar questions of fact and law presented in the cases, the claims have been centralized as part of a federal multidistrict litigation (MDL) before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, to reduce duplicative discovery, avoid conflicting pretrial rulings and serve the convenience of witnesses, parties and the court systems.

As product liability lawyers continue to review and file complaints for individuals who developed nontuberculous mycobacterim (NTM) infections following exposure to contaminated 3T Heater-Coolers used during open heart surgery, it is ultimately expected that there may be several hundred cases involved in the litigation.

On June 19, plaintiffs and defendants issued a joint proposed case management order (PDF), setting goals for case-specific and generic discovery over the next 120 days.

The order seeks to have parties agree on the contents of a Plaintiff fact sheet and Defendant fact sheet by the end of the month, as well as agreement on any possible protective order revisions. It also calls for Plaintiff fact sheets to be served 30 days after the court approves of the sheets, and the serving of completed Defendant fact sheets 60 days after that.

In addition, the agenda sets an October 5, 2018 date for plaintiff to conduct depositions of Defendant personnel, beginning discovery of two hospitals, and to begin written discovery and possible depositions of federal regulators, researchers and laboratories that may impact the litigation.

3T Heater Cooler Infection Risks

The Sorin 3T Heater-Cooler is a medical device commonly used during cardiac surgery and other procedures to help regulate blood temperature. However, litigation over the heater-coolers emerged after it was discovered that certain devices sold in recent years may have contaminated sterile operating rooms.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication, warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The post Case Management Plan for 3T Heater-Cooler Infection Cases Proposed in MDL appeared first on AboutLawsuits.com.

[lindamcsherry]

Contaminated Surgical Heater-Cooler Systems Cause Hundreds of Infections Each Year: CDC

Researchers warn that contaminated 3T Heater-Cooler systems may be responsible for nearly 300 invasive infections every year, which may not surface until long after the devices are used during heart surgery or other procedures, suggesting that mandatory reporting policies be implemented for nontuberculous mycobacterial (NTM) infections. 

In the March edition of Emerging Infectious Diseases, a journal published by the U.S. Centers for Disease Control and Prevention (CDC), Swiss researchers investigated how frequently patients undergoing surgery involving a 3T Heater Cooler devices (HCDs) were actually infected due to contaminated devices distributed worldwide in recent years.

The report warns that contaminated surgical heater-cooler systems have led to a “worldwide epidemic” of invasive Mycobacterium chimaera infections, which may remain dormant for months or even years after exposure, before resulting in life-threatening health complications.

Surgical heater-cooler systems are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems found in operating rooms nationwide were contaminated with bacteria, which may then be released in a mist into the operating room, where it may enter the sterile surgical site.

In this new report, researchers note that while Swiss officials were the first to identify the problem in 2014, it is unknown how widespread the surgical heater-cooler infections are on a global scale. To address that, researchers obtained data from a wide variety of sources, including the Swiss National Registry for Cardiac Surgery and the Swiss Federal Office of Statistics.

According to their findings, they estimate that there are 156 to 282 cases per year of new M. chimaera infections caused by contaminated 3T Heater Cooler systems in the 10 major cardiac valve replacement market countries.

“In summary, our data provide an estimate of the global burden of M. chimaera associated with open heart surgery, enabling policy makers to guide actions and to decrease the risk for transmission from HCDs. Our data suggest implementation of systematic lookback approaches in each country where LivaNova 3T HCDs have been used to optimize case finding,” the researchers concluded. “In addition, countries may consider mandatory reporting of invasive nontuberculous mycobacterial infections.”

As a result of the surgical heater-cooler infection risks, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated systems, recommending continued medical monitoring.

3T Heater Cooler Infection Lawsuits

Dozens of product liability lawsuits have been filed against the manufacturer of the device, on behalf of individuals diagnosed with NTM infections following heart surgery where a contaminated heater-cooler may have been used.

Given similar questions of fact and law raised in complaints pending in federal courts nationwide, the U.S. Judicial Panel on Multidistrict Litigation recently established consolidated pretrial proceedings for the cases, centralizing the claims before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.

In a safety communication issued last year, FDA officials highlighted concerns about the risk. At that time, the CDC also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Over the coming months and years, as additional heart surgery infections may be diagnosed and injury lawyers investigate additional claims, the size and scope of the litigation is expected to increase substantially.

The post Contaminated Surgical Heater-Cooler Systems Cause Hundreds of Infections Each Year: CDC appeared first on AboutLawsuits.com.

[lindamcsherry]

3T Heater-Cooler System Infections Found In 12 New Orleans Children’s Hospital Patients

Contaminated 3T Heater-Cooler Systems commonly used during heart surgery are believed to be responsible for infections among at least a dozen children at Children’s Hospital in New Orleans. 

Last week, the hospital issued a statement announcing that at least 12 children who underwent heart surgery between May and July 2017 have tested positive for Mycobacterium abscessus surgical site infections.

While the hospital did not mention the 3T Heater-Cooler system by name, other media outlets have confirmed that a medical device linked to similar heart surgery infections in recent years was involved in the treatment at the Children’s hospital.

“Because a common element in the affected children was open-heart surgery requiring the use of cardiopulmonary bypass, our investigation focused on the environment and equipment used in the cardiac operating room,” the hospital’s statement notes. “We believe a piece of equipment used to regulate the temperature of patients while on bypass is the most likely source of this infection, and all suspected equipment has been removed from service and replaced.”

The hospital has sent out at least 55 letters to patients who may have been exposed to the contaminated 3T Heater Cooler system.

A number of open heart surgery infection lawsuits filed in courts nationwide against the makers of the 3T Heater-Cooler, alleging that the contamination risk was known and inadequate steps were taken to warn the medical community, the FDA and heart surgery patients.

Similar hospital warning letters to heart surgery patients have been sent by other facilities nationwide, after it was discovered that problems with the 3T Heater-Cooler System were causing the heart surgery infections.

The FDA first warned about the heater-cooler infection risk following coronary bypass or other heart procedures in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air of the operating room.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Children’s Hospital in New Orleans has announced it will pay all clinical costs for treating and evaluating infections linked to the use of the 3T Heater Cooler system in its facility.

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[lindamcsherry]

More Than One in Three Heart Surgery Heater-Coolers Contaminated With Myobacterium Chimaera: Study

As reports of severe infections following heart surgery continue to surface worldwide, new research suggests that more than one-third of all 3T Heater-Cooler Systems commonly used during cardiac procedures appear to be contaminated with Mycobacterium chimaera, which can cause hard-to-detect and difficult to treat infections that surface months or years later. 

Researchers with Special Pathogens Laboratory announced that they tested 89 different 3T Heater-Cooler Systems between July 2015 and December 2016, and found that 33 of them were contaminated with M. chimaera. The findings were presented this week at the Annual Conference of the Association for Professionals in Infection Control and Epidemiology (APIC) and announced in an APIC press release on June 14.

Strains of M. chimaera and Mycobacterium abscessus (M. abscessus) have been linked to a growing number of infections worldwide that developed following open heart surgery, valve replacement, heart bypass and other cardiac procedures. Both are forms of non-tuberculosis mycobacteria (NTM) infections.

The heart surgery infections have been linked use of certain Sorin 3T Heater-Coolers, which are a medical device commonly found in operating rooms to regulate blood temperature. The devices are used in the vast majority of heart surgeries, but it was discovered last year that certain devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which can cause life-threatening infections to surface months or even years after exposure.

Contaminated vapors may be released by the devices, posing a serious risk for individuals with a compromised immune system and open chest cavity during the surgery, leading to multiple reports of Mycobacterium chimaera or Mycobacterium abscessus infections.

At the Conference, John Rihs, VP of Laboratory Services at Special Pathogens Laboratory announced that their researchers tested 653 water samples from 89 units from 23 different hospitals in 14 states, Canada and the District of Columbia. According to their findings, 33 of the units were contaminated with M. chimaera, and four of the units also tested positive for the bacteria that causes Legionnaire’s disease.

“Our results showed M. chimaera in 37 percent of units tested and is consistent with previous findings. The extent of contamination from such a rare organism in multiple units from all over the country was surprising,” Rihs said. “Some devices remained positive for M. chimaera for months, indicating that disinfection can be difficult and routine testing is advisable. Beyond M. chimaera, we found other NTM species, Legionella, and fungi, indicating these units are capable of supporting a diverse microbial population.”

The FDA first warned about the heart surgery infection risk from heater-cooler devices in October 2015, indicating that a large number of adverse event reports had been received in connection with the device.

In June 2016, a panel of experts were convened to evaluated the problems, indicating that at least 34 reports involving bacterial infections following heart surgery involving heater-cooler systems had been received between January 2010 and August 2015.

Late last year, the federal regulators issued a safety communication warning about the infection problems with 3T Heater-Coolers, indicating that water tanks used by the devices can become contaminated and spread contaminants to other parts of the system, where they can be released into the air.

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of M. Chimaera infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.”

The manufacturer, Sorin Group, currently faces a growing number of  M. chimaera infection lawsuits brought on behalf of individuals who were exposed to the contaminated 3T systems. As additional infections continue to surface in the coming months and years, the number of cases is expected to continue to grow, potentially involving hundreds of claims.

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[lindamcsherry]

Heart Surgery NTM Infection Class Action Lawsuit Filed Over 3T Heater-Cooler Problems

The manufacturers of the 3T Heater-Cooler System, which is commonly used during open heart surgery to control blood temperature, face a class action lawsuit over the risk of nontuberculous mycobacterium (NTM) infections following heart surgery, which may surface years after exposure to contaminated devices. 

Jeri Pickrell filed the complaint (PDF) against Sorin Group and Livanova PLC in the U.S. District Court for the District of Iowa on May 31, seeking class action status for all individuals in Iowa who were “unknowingly exposed to a potentially fatal bacteria during open heart surgery.”

Heart surgery infections have been linked to Sorin 3T Heater-Coolers, which are commonly used during bypass surgery, valve replacement surgery and other cardiac procedures. The devices involve the use of tanks that provide temperature controlled water used to regulate blood temperature. However, last year it was discovered that many devices manufactured prior to September 2014 may be contaminated with a slow growing bacteria, which can cause life-threatening infections to surface months or even years after exposure.

Contaminated vapors may be released by the 3T Heater-Cooler, posing a serious risk for individuals with a compromised immune system and open chest cavity during the surgery, leading to multiple reports of Mycobacterium chimaera infections, Mycobacterium abscessus infections or other NTM infections, which can lie dormant for months or even years before symptoms become obvious.

At least two hospitals in Iowa have warned patients who underwent major heart surgery or other procedures between January 1, 2012 and July 1, 2016 that they may have been exposed to the rare and potentially fatal bacteria through a 3T Heater-Cooler. Similar hospital letters about the NTM infection risk have been sent by other facilities nationwide, warning individuals to follow up with their physician.

“Symptoms of an NTM infection are very general and may include any combination of the following: fever, pain, redness, heat or pus around a surgical incision, night sweats, joint pain, muscle pain and fatigue,” according to the complaint. “Because NTM symptoms are non-specific and manifestation may take several weeks to several years, a patient will most likely fail to link the infection to his or her prior heart surgery, particularly as more time elapses between surgery and initial symptomology.”

The 3T Heater-Cooler class action lawsuit seeks medical monitoring of patients who may be at risk of NTM infections during surgical procedures involving 3T systems, also calling for the court to declare that the systems as defective and unsafe for their intended use.

“NTM infections are capable of early detection by way of existing scientific methods including, but not limited to, targeted culturing and DNA sequencing of invasive samples (e.g. blood, pus, tissue biopsy or implanted prosthetic material),” the lawsuit states. “Because NTM screening is not conducted in the absence of exposure to NTM, the prescribed monitoring regime is different than that normally recommended in the absence of exposure. Plaintiff and Class Members require specialized screening not within the purview of routine medical exams.”

3T Heater Cooler System Infection Risks

Concerns about the heater-cooler infection risk following heart surgeries first emerged in October 2015, when the FDA issued warnings about a large number of adverse event reports received in connection with blood heater-cooler devices.

In June 2016, a panel of experts were convened to evaluated the issue, indicating that at least 34 reports involving NTM infections following heart surgery where heater-cooler systems were used.

Late last year, the federal regulators issued a safety communication warning about contaminated 3T Heater-Coolers, indicating that water tanks used by the devices may spread contaminants to other parts of the system, where they can be released into the air of the operating room.

“If allowed within the operative field, NTM poses a significant health risk to surgical patients and patients with compromised immune systems,” the lawsuit filed by Waddell states. “Because NTM is a slow growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection, which most commonly results in pulmonary or cardiovascular disease.”

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of NTM infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

The class action claim comes amid a growing number of individual 3T Heater Cooler System infection lawsuits by plaintiffs who actually developed infections following procedures. As additional infections continue to surface in the coming months and years, the number of cases is expected to continue to grow, potentially involving hundreds of claims.

The post Heart Surgery NTM Infection Class Action Lawsuit Filed Over 3T Heater-Cooler Problems appeared first on AboutLawsuits.com.

[lindamcsherry]

Heart Surgery Heater-Cooler Caused NTM Infection, Lawsuit Claims

A South Carolina man diagnosed with a rare nontuberculous mycobacterium (NTM) infection following heart surgery has filed a product liability lawsuit against the makers of the 3T Heater-Cooler system, which was used to maintain his blood temperature during the procedure.

The complaint (PDF) was filed by Edward Ray Waddell in the U.S. District Court for the District of South Carolina on April 24, indicating that LivaNova PLC and Sorin Group manufactured and sold contaminated devices, which have been linked to severe and life-threatening NTM infections that surface months or even years after valve replacement surgery, cardiac bypass or other open heart procedures where the 3T Heater-Cooler has been commonly used.

Waddell indicates that he was exposed to a contaminated heart surgery heater-cooler during an aortic valve replacement and cardiac bypass grafting procedure in December 2013. The 3T system was used to regulate the temperature of his blood during the procedure. However, following the procedure, Waddell suffered deteriorating conditions, including a high-grade fever, weakness and developed pneumonia.

It was not until April 2014 that a red rash and bubbling began to appear around the surgical site. He was placed on antibiotics, had to undergo sternal debridement, and was fitted with a wound vac.

Later, Waddell underwent an additional debridement, and also had a pectoralis major muscle flap procedure. The lawsuit indicates that this has severely affected his ability to use his arm.

He was diagnosed with an M. abscessus infection, which is a form of nontuberculous mycobacterium (NTM) infection, which resulted in an aortic aneurysm, according to the lawsuit. Several years later, Waddell indicates that he is still receiving treatment for the heart surgery infection.\

3T Heater Cooler System Infection Risks

Concerns about the heater-cooler infection risk following heart surgeries first emerged in October 2015, when the FDA issued warnings about a large number of adverse event reports received in connection with blood heater-cooler devices.

In June 2016, a panel of experts were convened to evaluated the issue, indicating that at least 34 reports involving NTM infections following heart surgery where heater-cooler systems were used.

Late last year, the federal regulators issued a safety communication warning about contaminated 3T Heater-Coolers, indicating that water tanks used by the devices may spread contaminants to other parts of the system, where they can be released into the air of the operating room.

“If allowed within the operative field, NTM poses a significant health risk to surgical patients and patients with compromised immune systems,” the lawsuit filed by Waddell states. “Because NTM is a slow growing bacterium, it generally takes anywhere from two weeks to four years before manifestation of an NTM infection, which most commonly results in pulmonary or cardiovascular disease.”

The U.S. Centers for Disease Control and Prevention (CDC) also issued a Health Alert Network advisory over the potential risk of NTM infections following heart surgery, indicating that about 60% of the 250,000 heart bypass procedures performed each year in the United States involve use of affected 3T Heater-Cooler systems.

Waddell’s complaint is one of a growing number of other NTM infection lawsuits filed nationwide over the 3T Heater-Cooler, alleging that the manufacturers knew about the risk of contamination and failed to adequately warn the medical community, the FDA, and patients of the risks.

Over the coming months, it is expected that additional cases will be filed, as individuals and families learn that problems experienced following heart surgery may be related to the use of a 3T Heater-Cooler.

The FDA is now advising facilities using 3T devices to remove the devices and any accessories from service if they have tested positive for the bacteria, or have been linked to patients who later were identified as infected. The agency also recommends using new accessories, tubing and connectors if using a new heater-cooler device, channeling exhaust from the devices away from patients and into an operating room exhaust vent, and to review the recommendations in the CDC’s health advisory.

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