#Sorin 3T Heater Cooler Systems

[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. 

[lezdotechmed]

Heater-Cooler Infection: Heater-Cooler Devices' Regrettable Hazards

Nontuberculous mycobacteria (NTM) is a microorganism that can cause serious, potentially fatal diseases. Due to their weakened immune systems, patients having cardiothoracic procedures are especially vulnerable. A specific form of bacteria called NTM has been directly connected to heater-cooler units.

Even though the water used in the heat exchanges may not always be contaminated with hazardous bacteria, there has been another important problem that has raised the possibility of serious infection. In the water inside the tank, there is a chance that bacteria will develop. Even though it doesn't directly contact the sufferer, this substance enters the surrounding air. The potential pathogen enters the patient's body through the surgical field, which is sterile because the patient's chest is exposed throughout the procedure.

The FDA released a safety communication in 2015, warning the general public and medical professionals about a severe, perhaps lethal strain of bacteria linked to heater-cooler products.

Claims against the Sorin Group and its affiliates are made in the Sorin Stöckert 3T Heater-Cooler cases. LivaNova PLC and Cyberonics Inc. are included in this. Heater-Cooler infection cases are based on the idea that the maker ought to have been aware that their product might spread bacteria and result in fatal diseases.

The 3T heating and cooling system, manufactured by LivaNova PLC, is still facing legal action because it may increase the risk of heater-cooler infections in patients who have had heart surgery. The complaints contend that LivaNova failed to alert hospitals and doctors to these dangers. When a person, team, or employer acts irresponsibly and injures another, this is negligence.

In federal court, there are multiple Sorin Stockert 3T Heater lawsuits that are still active. Multidistrict litigation involving these cases is currently taking place in the Eastern District of Pennsylvania. There were 135 cases filed as of May 2018, but the number is still rising and will continue to do so because the infection can take years to manifest. The lawsuits that are currently pending in federal court have been discussed as potential settlements.

The Sorin 3T units are accused in the product liability lawsuits of having a significant design flaw that makes them encourage the growth and spread of bacteria on patients during operations involving an open chest cavity.

You might be eligible to file a lawsuit if you or a loved one underwent a procedure that involved the Stockert 3T device and afterwards developed a bacterial heater-cooler infection. You may also be entitled to damages, which could include, past and future medical costs, pain and suffering, emotional anguish, wage loss, and wrongful death (if an infection caused a loved one's passing).

Your injuries, their circumstances, and the treatment and therapy you need will all affect how much compensation you get for an accident caused by a poor medical device. The medical record review services offered by LezDo techmed make it simple for attorneys to identify the benefits and drawbacks of the heater-cooler cases. From our site, you can read more blogs like, singulair lawsuits, Unilever dry shampoo recall and insulin pump lawsuits.

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[safetyrecalls]

LivaNova USA Inc. - Stockert HeaterCooler System 3T - Class 2 Recall

SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volume 6 liters. " One interchangeable heating/cooling circuit for cardioplegia heat-exchanger, temperatures ranging from 2 degrees Celsius to 10 degrees Celsius (cooling tank) and/or from 15 degrees Celsius to 41 degrees Celsius (heating tank). If required, the circuits for the patient and the circuit for cardioplegia can be switched off separately, in order to increase the activated functional group s heating and/or cooling performance. Product Usage: The Stockert Heater-Cooler System 3T is intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

[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.

[davidslepkow]

Cases we are reviewing for potential lawsuits:

Defective medical device lawsuits

Endoscope/ Duodenoscope Superbug Infection Lawsuit

PENTAX ED-3490TK Video Duodenoscope

Olympus TJF-Q180V Duodenoscope

Bayer Essure birth control lawsuits

Hernia mesh

Depuy Pinnacle Hip replacement lawsuits

IVC Filter lawsuit

Sorin Stockert 3T Heater- Cooler lawsuit

Bair Hugger warming blanket

Medtronic Insulin Pumps

Mirena IUD-Bayer

Laparoscopic power morcellators

Paragard IUD

Granuflo- naturalyte

asbestos – mesothelioma lawsuit

Defective hip implants-  metal on metal hip replacement lawsuit

Depuy ASR XL Acetabular Hip Replacement System

DePuy® Pinnacle® Modular Hip Replacement System

Zimmer Durom Cup Hip replacement failure

Stryker Rejuvenate lawsuit

Stryker® LFIT V40 Femoral Head hip implant lawsuit

Stryker® ABG II Modular-Neck Hip Stems

Wright hip implant lawsuit

Wright Medical Technology Hip Replacements (Conserve®, Dynasty®, Profemur® and Lineage® line of products)

Wright hip stem fracture?

Zimmer Knee Replacement lawsuit

Zimmer NexGen Knee Replacement Lawsuit

Stryker Triathlon Knee replacement

Defective auto part / automobile defect lawsuits

Gm Ignition defects recall / GM Recall – Ignition Switch defect

Ford fires

Ford Speed Control Deactivation Switch defects (Ford SCDS Fires)

Rollover accidents

Defective airbag lawsuit

Airbags |airbag defect

Takata exploding airbag

Seatbelt defect

Rollover/Roof Crush defect

Steering, Braking defect

Defective auto parts causing serious injury or death

Asbestos related diseases- mesothelioma

Defective products in general

Defective product recall causing catastrophic injury and death

Toxic mold

Monsanto Roundup Lawsuits- non hodgkin’s lymphoma

Talcum powder lawsuits causing  ovarian cancer- mesothelioma- fallopian tube cancer- Johnson & Johnson- asbestos

Methylene Chloride, toxic paint stripper

3M Combat Arms Earplugs- military earplug lawsuit

Defective drugs- bad drug lawsuit

Zofran — (Ondansetron hydrochloride) Zoloft- birth defect lawsuit

Accutane

Botox injections

Nuplazid (for treatment of Parkinson’s symptoms/  Nuplazid may cause heart attack or death)

Fosamax

Boniva

Actoneli

Risperdal

Xarelto, Blood clot medication

Mirena IUD

Valsartan- Blood pressure medication causing stomach cancer, liver cancer, acute liver injury or colorectal cancer, 1 year of exposure

Viberzi lawsuit

Zinbryta® (daclizumab) litigation

Testosterone replacement therapy

Pradaxa

Chantix

Nuplazid Parkinson’s disease drug lawsuits

Onglyza and Kombiglyze XR- diabetes medication- heart failure

Taxotere- Chemotherapy drug

Antidepressants (SSRI’s)

Zoloft®

Prozac®

Paxil®

Celexa®

Effexor (venlafaxine) causing birth defects

Gadolinium Toxicity lawsuit

Bayer Healthcare Pharmaceticals

GE Healthcare

Guerbet llc.

Liebel- Flarsheim Company LLC. (subsidiary of Guerbet llc.)

Type 2 diabetes medication (Incretin Mimetics)

Januvia (sitagliptin)

Victoza

Janumet

Byetta

Proton Pump Inhibitor Lawsuit PPI

Nexium

Prevacid

Prilosec

Protonix (pantoprazole)

AcipHex (rabeprazole)

Dexilant (dexlansoprazole)

Zegerid (omeprazole and sodium bicarbonate)

Vimovo (esomeprazole and naproxen)

SGL2 inhibitor for type 2 diabetes lawsuit- causing death, kidney failure, heart attack, amputation or Diabetic Ketoacidosis(type 2 sodium-glucose co-transporter)

Invokana (canagliflozin)

Invokamet (active ingredients: canagliflozin and metformin)

Farxiga (dapagliflozin)

Xigduo XR® (active ingredients: dapagliflozin and metformin extended-release)

Jardiance (active ingredient: empagliflozin)

Glyzambi (active ingredients: empagliflozin and linagliptin);

Synjardy (active ingredient: empagliflozin and metformin).

PDE5 inhibitors, risk for developing skin cancer

Viagra (Generic: sildenafil)

Cialis (Generic tadalafil)

Revatio

Adcirca

Drugs causing severe reaction (Stevens-Johnson syndrome)

Tylenol® Acetaminophen

Allopurinol®

Carbamazepine (mood stabilizers such as Tegretol®)

Celebrex® or other Cox-2 inhibitors

Dilantin®and Phenytoin®

Ibuprofen (Advil®and Motrin®)

Nonsteroidal anti-inflammatory drugs (Daypro®, etc.)

sulfa antibiotics

Vehicular accidents and negligence causing catastrophic injury or death

Bus crash caused by negligence or not following regulations or safety protocols

Truck accidents

Motorcycle accidents

If you are a victim of a defective product, medical drug, defective automobile or bad prescription medication, contact us! If you need to file a defective medical device lawsuit or a defective product liability lawsuit, contact a defects attorney at the number above.

“If you have been injured or suffered other damages because of a product you used, you may have a defective product liability claim. Though the range of defective product cases is broad, the claims typically fall into three categories of product liability: (1) defective manufacture; (2) defective design; or (3) failure to provide adequate warnings or instructions concerning the proper use of the product.” https://www.nolo.com/legal-encyclopedia/types-of-defective-product-liability-30070.html

Defective medical devices

“Dangerous or defective medical devices — such as faulty surgical instruments, implants, pacemakers, and prosthetics — can give rise to a product liability claim if a person who undergoes surgery or uses a medical device is injured or dies as a result. Although closely monitored by the U.S. Food and Drug Administration (FDA), a product can be defective in its design, manufacturing process, or marketing strategy. In most instances, state lawsuits over federally-approved medical devices face stringent legal obstacles and often receive increased national attention. Below, you will find resources that highlight common high-risk medical devices such as stents and defibrillators, and links to product liability lawyers in your area, as well as helpful forms and other resources. Please select from the links below to get started.” https://injury.findlaw.com/product-liability/defective-medical-devices.html

Defective auto parts and defective cars and automobiles- vehicle recalls

“Vehicle recalls and defects are not only an inconvenience but can also lead to serious accidents and injuries. If your car or vehicle is subject to a recall, you have certain rights as a consumer. In addition, if you were injured as a result of a vehicle defect, a product liability suit may be in order. This section provides an overview of vehicle defects and the recall process, information on your legal rights if you have a defective vehicle, and more. Here, you can also research the safety ratings and recall history of vehicles and equipment like tires and children’s car seats.”  https://injury.findlaw.com/product-liability/vehicle-recalls-and-defects.html

Bad drug lawsuits- defective prescription medication

“Defective Drugs Law falls under Product Liability law, is closely related to Pharmaceutical law and often overlaps with Medical Malpractice law.  As in all product liability claims, defective drug claims are based on three defect categories:  – Manufacturing defects – the pharmaceutical drug is manufactured improperly or the drug has become contaminated during the process and causes harm to the end user.  – Design defects (Dangerous side effects) – the pharmaceutical drug was manufactured correctly, but the side effects caused by the drug cause harm or injury. – Failure to Warn (Defective marketing) – a failure to provide sufficient or appropriate instructions, warnings, or recommendations for the use of the drug.  Defective drug claims can result in a great many different defendants: the manufacturer; testing laboratory; pharmaceutical sales representative; prescribing physician; clinic or hospital; and the pharmacy. When suing a hospital or physician for a drug product liability claim, the plaintiff may also have a medical malpractice claim.” https://www.hg.org/defective-drugs-law.html

[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/

[safetyrecalls]

LivaNova USA Inc. - Stockert/Sorin HeaterCooler System 3T - Class 2 Recall

SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

[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.

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[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.

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[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.

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[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.

[safetyrecalls]

LivaNova USA - Stckert HeaterCooler System 3T - Class 2 Recall

Sorin St¿ckert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

[lindamcsherry]

Lawyers Seek Leadership Roles in 3T Heater-Cooler Infection Lawsuits

Following the recent consolidation of all 3T Heater-Cooler infection lawsuits filed throughout the federal court system, an application has been filed by a group of plaintiffs attorneys who seeking leadership roles in the multidistrict litigation (MDL). 

The 3T Heater-Cooler is a medical device commonly used during open heart surgery, which has been linked to reports of nontuberculous mycobacterim (NTM) infections, which may develop months or even years after surgery.

The devices are used to regulate blood temperature during surgery. However, in late 2015, it was discovered that certain Sorin 3T Heater-Cooler systems were contaminated with bacteria, which is then released in a mist that may enter the sterile surgical site.

The bacteria may cause difficult to treat internal infections, which typically do not surface until long after exposure. As a result of the risk, hospitals nationwide have sent letters to thousands of heart surgery patients who may have been exposed to a contaminated 3T Heater-Cooler, recommending continued medical monitoring.

There are currently more than 50 product liability lawsuits pending against the makers of the 3T Heater-Cooler, which have all been centralized before U.S. District Judge John E. Jones III in the Middle District of Pennsylvania, for coordinated discovery and pretrial proceedings.

On May 15, a group of plaintiffs’ attorneys filed a joint application (PDF), calling for the establishment of a plaintiffs’ leadership group, including the appointment of an attorney as lead and liaison counsel, and the formation of a Plaintiffs’ Executive Committee, consisting of six other attorneys. These attorneys would take certain actions during the litigation that benefit all cases, while each individual plaintiff’s own lawyer would be responsible for deadlines and establishing causation in the separate cases.

The organization of the leadership positions will be discussed at an case management conference scheduled for May 31, according to a proposed agenda (PDF) filed this week.

On May 16, the parties also filed a proposed case management plan (PDF), which addresses the potential consolidation or grouping of cases or issues, the scope of discovery and dispute resolution, proposed protective orders, proposed mediation procedures and other issues.

The plan notes that a number of cases have already been given trial dates throughout 2019 and 2020, by Chief District Judge John A. Jarvey of the Southern District of Iowa, before the claims were consolidated. The plaintiffs request that Judge Jones accelerate case specific discovery in those cases, and maintain the established trial order, but push back the original trial dates.

3T Heater Cooler Infection Risks

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 Lawyers Seek Leadership Roles in 3T Heater-Cooler Infection Lawsuits 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.

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