#Sorin Stockert 3T

[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.

[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.

[cassandradodds]

What are the Essential Components of a Wrongful Death Lawsuit?

What is Wrongful Death?

A wrongful death means that a person died due to the wrongful conduct of another party. When a wrongful death occurs, the representative of the deceased person can file a wrongful death lawsuit. Wrongful death liability can include a variety of situations, including death from a car accident, a defective product, occupational hazards, police misconduct, and more.

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in various lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a wrongful death lawsuit.

When a wrongful death occurs, only the personal representative of the deceased person can file a wrongful death lawsuit. In New York, this representative is appointed by Surrogate’s Court. To pursue litigation over a wrongful death, the representative must show several things. The suit must demonstrate that the defendant acted with negligence; in other words, the liable party must have acted carelessly. Additionally, you must show that the death resulted from this negligence.

In a lawsuit alleging wrongful death, the representative must show that the deceased left behind surviving beneficiaries or dependents. This includes a spouse or children. The plaintiff must also show that the death caused the survivors to endure economic loss.

When recovering damages in a wrongful death case, the plaintiff can only recover for economic loss and conscious pain and suffering of the deceased person. Wrongful death lawsuits do not provide recovery for grief on behalf of the survivors.

Example of economic damages you can recover in a wrongful death lawsuit include medical expenses for the deceased. For example, a wrongful death claim is filed on behalf of a man who died of injuries related to a car accident caused by someone else’s negligence. Economic damages may include the cost of medical bills used to treat him from the time the accident occurred up until his death. Other examples may include the cost of nursing care, assisted living, and funeral expenses. Children of the deceased individual can also seek recovery for loss of parental nurturing, guidance and education.

If you are thinking of pursuing a wrongful death lawsuit, contact a personal injury lawyer at Parker Waichman today. Our attorneys are well-versed in personal injury litigation, and can provide assistance as you go through the legal process. Be sure to document your claim the best of your ability, and start probating the deceased’s estate so that court can appoint a personal representative.

Sometimes, the court may determine that a party is liable for someone’s death in a civil trial but not a criminal trial. This is due to the lower standard of proof required for civil trial.

Wrongful Death Lawsuits and Product Liability Litigation

The firm is actively involved in product liability litigation, in which manufacturers are held liable for a defective product. In some cases, the defective product leads to serious, even fatal injuries. Product liability lawsuits are often filed over allegedly defective drugs and medical devices.

For example, Bayer and Janssen are facing product liability lawsuits over the anticoagulant drug Xarelto. Plaintiffs in the litigation allege that the drug caused uncontrollable bleeding and that the manufacturers failed to warn of the risks. Some of these lawsuits are wrongful death cases because the bleeding was fatal. Court records show that one such lawsuit was filed on behalf of a Xarelto user who died in March 2015. According to the complaint, the decedent took the blood thinner for roughly one year and suffered from bleeding the lungs, ischemic stroke, multiple cardiopulmonary arrests, respiratory failure and septic shock.

The Xarelto wrongful death lawsuit alleges that the decedent died because of the drug maker’s wrongful conduct. Specifically, the complaint focuses on the defendants’ failure to warn about the lack of an antidote to any bleeding in case it begins. Other anticoagulants (i.e. warfarin) have a reversal agent that can be used if patients suffer excessive bleeding. The lawsuit alleges the manufacturers knew about this risk, but failed to adequately warn patients or the medical community.

LivaNova (formerly Sorin Group) is also facing some wrongful death lawsuits related to product liability litigation. The company manufactures its Stockert 3T heater-cooler device, which is used to maintain a patient’s body temperature during surgery. However, these systems have been implicated in a global outbreak of infections caused by nontuberculous mycobacterium (NTM). These infections occur in patients undergoing open heart surgery. One wrongful death lawsuit was filed on behalf of a decedent who suffered an NTM infection after heart surgery using the 3T. The hospital who performed the surgery sent 180 letters to patients informing them of potential contamination.

The lawsuit alleges that the plaintiff died due to the infection, and that the infection was caused by the wrongful conduct of LivaNova. The plaintiff alleges that the company failed to act appropriate to protect patients.

Manufacturers of inferior vena cava (IVC) filters, specifically C.R. Bard and Cook Medical, are also facing wrongful death claims. Plaintiffs allege that the devices, which are used to trap blood clots, are defective and cause serious injuries. Specifically, complaints allege that the filters break inside the blood vessels and the fragments migrate elsewhere, sometimes ending up in critical areas like the heart tissue.

Wrongful death claims often involve medical product, but other products are subject to product liability as well. For example, Ikea is facing litigation overs its dressers, which came under fire after several children died due to a toppled dresser. A total of 29 million Ikea dressers were recalled following reports of these fatalities.

The parents of one deceased toddler filed a wrongful death lawsuit in January 2016 in the Philadelphia Common Pleas Court. According to the complaint, the toddler’s death was caused by the defective nature of the dresser. The suit alleges that Ikea sold the dressers despite knowing that they were unstable, easily tipping over onto children.

Filing a Wrongful Death Lawsuit

If you or someone you know is interested in filing a wrongful death lawsuit, contact a personal injury attorney at Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/what-are-the-essential-components-of-a-wrongful-death-lawsuit/

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[parkerwaichmanlaw]

What are the Essential Components of a Wrongful Death Lawsuit?

What is Wrongful Death?

A wrongful death means that a person died due to the wrongful conduct of another party. When a wrongful death occurs, the representative of the deceased person can file a wrongful death lawsuit. Wrongful death liability can include a variety of situations, including death from a car accident, a defective product, occupational hazards, police misconduct, and more.

The personal injury attorneys at Parker Waichman LLP have decades of experience representing clients in various lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a wrongful death lawsuit.

When a wrongful death occurs, only the personal representative of the deceased person can file a wrongful death lawsuit. In New York, this representative is appointed by Surrogate’s Court. To pursue litigation over a wrongful death, the representative must show several things. The suit must demonstrate that the defendant acted with negligence; in other words, the liable party must have acted carelessly. Additionally, you must show that the death resulted from this negligence.

In a lawsuit alleging wrongful death, the representative must show that the deceased left behind surviving beneficiaries or dependents. This includes a spouse or children. The plaintiff must also show that the death caused the survivors to endure economic loss.

When recovering damages in a wrongful death case, the plaintiff can only recover for economic loss and conscious pain and suffering of the deceased person. Wrongful death lawsuits do not provide recovery for grief on behalf of the survivors.

Example of economic damages you can recover in a wrongful death lawsuit include medical expenses for the deceased. For example, a wrongful death claim is filed on behalf of a man who died of injuries related to a car accident caused by someone else’s negligence. Economic damages may include the cost of medical bills used to treat him from the time the accident occurred up until his death. Other examples may include the cost of nursing care, assisted living, and funeral expenses. Children of the deceased individual can also seek recovery for loss of parental nurturing, guidance and education.

If you are thinking of pursuing a wrongful death lawsuit, contact a personal injury lawyer at Parker Waichman today. Our attorneys are well-versed in personal injury litigation, and can provide assistance as you go through the legal process. Be sure to document your claim the best of your ability, and start probating the deceased’s estate so that court can appoint a personal representative.

Sometimes, the court may determine that a party is liable for someone’s death in a civil trial but not a criminal trial. This is due to the lower standard of proof required for civil trial.

Wrongful Death Lawsuits and Product Liability Litigation

The firm is actively involved in product liability litigation, in which manufacturers are held liable for a defective product. In some cases, the defective product leads to serious, even fatal injuries. Product liability lawsuits are often filed over allegedly defective drugs and medical devices.

For example, Bayer and Janssen are facing product liability lawsuits over the anticoagulant drug Xarelto. Plaintiffs in the litigation allege that the drug caused uncontrollable bleeding and that the manufacturers failed to warn of the risks. Some of these lawsuits are wrongful death cases because the bleeding was fatal. Court records show that one such lawsuit was filed on behalf of a Xarelto user who died in March 2015. According to the complaint, the decedent took the blood thinner for roughly one year and suffered from bleeding the lungs, ischemic stroke, multiple cardiopulmonary arrests, respiratory failure and septic shock.

The Xarelto wrongful death lawsuit alleges that the decedent died because of the drug maker’s wrongful conduct. Specifically, the complaint focuses on the defendants’ failure to warn about the lack of an antidote to any bleeding in case it begins. Other anticoagulants (i.e. warfarin) have a reversal agent that can be used if patients suffer excessive bleeding. The lawsuit alleges the manufacturers knew about this risk, but failed to adequately warn patients or the medical community.

LivaNova (formerly Sorin Group) is also facing some wrongful death lawsuits related to product liability litigation. The company manufactures its Stockert 3T heater-cooler device, which is used to maintain a patient’s body temperature during surgery. However, these systems have been implicated in a global outbreak of infections caused by nontuberculous mycobacterium (NTM). These infections occur in patients undergoing open heart surgery. One wrongful death lawsuit was filed on behalf of a decedent who suffered an NTM infection after heart surgery using the 3T. The hospital who performed the surgery sent 180 letters to patients informing them of potential contamination.

The lawsuit alleges that the plaintiff died due to the infection, and that the infection was caused by the wrongful conduct of LivaNova. The plaintiff alleges that the company failed to act appropriate to protect patients.

Manufacturers of inferior vena cava (IVC) filters, specifically C.R. Bard and Cook Medical, are also facing wrongful death claims. Plaintiffs allege that the devices, which are used to trap blood clots, are defective and cause serious injuries. Specifically, complaints allege that the filters break inside the blood vessels and the fragments migrate elsewhere, sometimes ending up in critical areas like the heart tissue.

Wrongful death claims often involve medical product, but other products are subject to product liability as well. For example, Ikea is facing litigation overs its dressers, which came under fire after several children died due to a toppled dresser. A total of 29 million Ikea dressers were recalled following reports of these fatalities.

The parents of one deceased toddler filed a wrongful death lawsuit in January 2016 in the Philadelphia Common Pleas Court. According to the complaint, the toddler’s death was caused by the defective nature of the dresser. The suit alleges that Ikea sold the dressers despite knowing that they were unstable, easily tipping over onto children.

Filing a Wrongful Death Lawsuit

If you or someone you know is interested in filing a wrongful death lawsuit, contact a personal injury attorney at Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/what-are-the-essential-components-of-a-wrongful-death-lawsuit/

[cassandradodds]

LivaNova Faces New Sorin Stöckert 3T Heater-Cooler Lawsuit

New Lawsuit Alleges M. chimaera Infection with 3T Heater-Cooler

Litigation is mounting over the Sorin Stöckert 3T Heater-Cooler System, marketed by LivaNova. Plaintiffs allege that the device, which is used to maintain the temperature of a patient’s blood and vital organs during surgery, caused a bacterial infection. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both issued warnings for the heater-cooler devices, after evidence linked them to global infections.

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) 3T Heater-Cooler lawsuit.

According to court records, a new lawsuit was filed in the U.S. District Court in South Carolina. The plaintiff is a South Carolina man who underwent a coronary artery bypass grafting procedure. The Sorin Group Stöckert 3T Heater-Cooler was used during the procedure. The suit alleges that the systems are contaminated with Mycobacterium chimaera, a type of nontuberculous mycobacterium (NTM). The plaintiff underwent the operation in April 2014, and doctors identified an infection at the surgical site two months later. According to the lawsuit, the plaintiff has endured multiple surgeries and antibiotic therapy.

The suit alleges negligence, breach of express warranty, breach of implied warranties, negligent misrepresentation, misrepresentation by omission, violation of South Carolina Unfair Trade Practices and loss of consortium.

The FDA and CDC have warned of possible NTM infections with heater-cooler devices. M. chimaera, a type of NTM, is a slow-growing bacterium that may not produce symptoms for long periods of time. Signs of NTM infection may include:

• Night sweats • Muscle aches • Weight loss • Fatigue • Unexplained fever

Regulators have warned that the 3T heater-cooler devices may spread the bacteria through the water. Even though the water in the systems does not make direct contact with patients, bacteria can be aerosolized (spread through the air).

Studies Link Heater-Coolers to Global M. Chimaera Infections

A Swiss study published in November 2016 showed that the heater-coolers are the likely source of a global outbreak of M. Chimaera infections. Findings were published in the Infection Control & Hospital Epidemiology, the journal of the Society for Health Epidemiology of America. The lead author was 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,” said Sommerstein. “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,” Sommerstein stated. The link between NTM infections and heater-cooler devices has been hard to identify because the bacteria grow slowly. Patients may not show symptoms for long periods of time. Even when symptoms do arise, they may easily be mistaken for another condition. In Europe, for example, some patients with NTM infections were not diagnosed until four years later.

The authors of the recent study advised that patients be screened for M. chimaera infections if they have an unexplained fever after open heart surgery, heart transplantation or were exposed to ventricular assist devices. Additionally, the systems should not be located near critical medical areas.

Genetic fingerprinting linked NTM infections to a single source where the Stöckert 3T Heater-Coolers were manufactured in Germany, Washington Post reported in October 2016. The finding suggest that half a million heart surgery patients may be at risk for infection. In addressing the findings, the FDA said that whole genome sequencing results “strongly suggest the 3T heater-cooler units are the source of M. chimaera contamination.”

The CDC also commented on the findings, stating “Although thousands of patients in the United States have been notified regarding potential exposure to contaminated heater-cooler devices, the number who were exposed might be much larger,”

Filing a Sorin 3T Heater-Cooler Lawsuit

If you or someone you know suffered an infection after undergoing surgery involving a Sorin 3T heater-cooler system, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information about filing a Sorin 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/19767-2/

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