Sorin Stockert 3T Heater-Cooler System Infection and Stockert Lawsuits

The Stöckert 3T heater-cooler system, a medical device that regulates a patient’s body temperature during certain surgeries, has been linked to a life-threatening infection. Also known as the Sorin Stockert Heater-Cooler System, the Stockert 3T manufactured by LivaNova (formerly Sorin), is the most commonly used heater-cooling system.

Sorin Stockert lawsuits allege that the Sorin 3T units have a major design defect that causes them to stimulate the growth and spread of bacteria on patients during surgical procedures involving an open chest cavity. This includes all types of heart and cardiovascular surgeries, which are the most common type of surgical procedures-- meaning the Sorin 3T defective device can potentially affect hundreds of thousands of people.

Hundreds of heater-cooler lawsuits have been filed after patients suffered serious side effects like heart or lung infection, coughing up blood and abdominal abscesses. These product liability lawsuits have been filed against LivaNova PLC (formerly Sorin Group Deutschland GmbH), the manufacturer of the Sorin Stockert 3T heating-cooling system, alleging failure to warn hospitals and doctors of the increased risk of infections caused by the medical device during cardiothoracic surgeries and for failing to provide adequate procedures or information about the need for cleaning and disinfecting.

 

Lawsuits are also aimed at the hospitals where surgeries took place. Swiss researchers reported in Emerging Infectious Diseases (October 2016) that Heater–Cooler Units (HCUs) seem to provide favorable environmental conditions for growth of NTM, in particular M. chimaera. “An intensified cleaning and disinfection protocol failed to prevent growth of NTM entirely but succeeded in preventing detectable aerosolization of M. chimaera…The contamination status of HCUs seems to be influenced by the intensity of maintenance, especially frequency of water changes.”

The first Sorin 3T-related infection complaints were filed in 2016. Lori Weinacker filed the first Sorin 3T heater-cooler complaint in a South Carolina federal court. She claimed her husband, Henry Weinacker, died of an infection following a heart bypass surgery using a Sorin 3T device in 2014.

The number of complaints grew quickly as several hospitals alerted patients that they may have been exposed to bacterial contamination. Some patients had suffered for months — or even years — unaware that their medical conditions were due to a bacterial infection.

The most recent Sorin Stockert 3T lawsuit was filed November 2021 in Los Angeles against Livanova , Kaiser Foundation Health Plan and Kaiser Hospitals and Southern California Permanente Medical Group.  Attorney Steven Gambardella filed the suit on behalf of Angel Ishkhanian’s estate: she contracted an infection caused by Mycobacterium Chimaera after undergoing open-heart surgery in 2014 that required a Stockert 3T.  Ms. Ishkhanian appeared to recover well from surgery and was discharged from the hospital on January 30, 2014.  She later complained of excessive fatigue, loss of appetite, unintentional weight loss, intermittent fevers, chills and other symptomatology associated with M. Chimaera/NTM bacterial infection.

Before her death, Ishkhanian’s physicians told her that this infection was likely caused by her exposure to a Stockert 3T, according to the lawsuit.

At least four Stockert class action lawsuits have been filed: two were dismissed and one demands the devices’ manufacturer arrange for monitoring of patients who underwent surgery with the devices. A national class action was filed in May 2021 in Toronto on behalf of every person in Canada who underwent open chest cardiac surgery “during which the Sorin 3T Heater-Cooler System was used at one of a specified list of 34 cardiac surgery institutions between January 1, 2010 and the last date that the implicated 3T Heater-Cooler System was used at that institution”, according to Global News.

HEATING-COOLING SYSTEMS

Heater-cooler devices include water tanks (Stockert system comprises three tanks) that provide temperature-controlled water to heat exchangers or blankets, which then provide cooling or warmth to the patient's body. Water in the circuits does not directly contact the patient. There is potential, however, for contaminated water to enter other parts of the unit or to aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient.

STOCKERT ASSOCIATED WITH NTM INFECTION

One particular type of bacteria, Mycobacterium chimaera, has been found growing in the tanks of the Stockert 3T device. M. chimaera is a type of nontuberculous mycobacterium (NTM) and one species of the same type of bacteria which causes tuberculosis.

NTM infections are serious bacterial infections caused by one of more than 150 types of bacteria, the most common of which are M. chimaera, M. abscessus and M. fortuitum. NTM does not normally pose a serious risk to healthy people, but patients undergoing open-heart or other invasive chest or abdominal surgery are at risk of a fatal infection associated with the Stockert device.

NTM is mostly associated with the Stӧckert 3T system, in part because it is used in about 60 percent of the 250,000 surgeries performed in US each year requiring a heater-cooler device. The bacteria were frequently found growing in the Stockert 3T tanks during a five-year period beginning in 2010.  According to the FDA, 12 deaths and 79 serious infection events were reported between 2010 and 2016.

The CDC estimates that as many as 1 in 100 people could be affected by serious complications from an NTM infection after undergoing cardiac surgery. Researchers have found that NTM could become airborne through a vent in the device and land in the patient’s chest cavity during surgery. Symptoms can sometimes take months to appear, and they are often non-specific, which makes diagnosing the problem difficult: some infections can take months to discover, increasing the potential for serious complications and a risk of death. 

Stockert 3T and NTM – Timeline

August and September 2014: M. chimaera contamination was found during tests at Sorin, the manufacturing facility, meaning that Sorin knew their products were contaminated. The contamination was found on the production line and water supply at Sorin. Units from this facility were shipped worldwide. Health authorities in the EU found that contamination likely originated in the factories that manufactured the Stockert 3T devices. The investigation found that the strains of bacteria in infected patients were genetically linked to bacteria found in German manufacturing facilities.

June 2015: Sorin recalled 1,755 of its 3T Heater-Cooler Systems.

August 2015: the FDA inspected LivaNova’s Munich manufacturing plant and the agency sent inspectors to the company’s Arvada. The FDA later issued a notice saying inspectors found conditions in the Munich plant that did not conform to FDA standards.

October 2015: The FDA issued its first safety communication stating that contaminated Sorin Stöckert 3T heater-cooler devices could put patients at increased risk of getting a life-threatening mycobacterial infection. It received 32 adverse event reports on heating, warming, cooling devices (not specifically the 3T) and said they were seeing people with NTM infections.

Sorin merged with Cyberonics, Inc. and the new company was named LivaNova. The Sorin 3T devices were originally branded as the Stockert 3T Heater-Cooler System. The Sorin Group originally manufactured the devices.

June 2016: FDA executive summary comprises 42 pages, including detailed FDA timeline of infections and actions, from Summer 2014 through Spring 2016.

October 2016: The CDC and the FDA issued a 3T Heater-Cooler warning that provides health officials with additional recommendations on how to prevent the spread of infection. While the FDA says that developing the M. chimaera infection is rare, it warns that the infection may take months or even years to develop.
The CDC reported a genetic similarity between strains of NTM found in patients and in the devices used at hospitals in Iowa and Pennsylvania. The report said devices made before Aug. 18, 2014 may have been contaminated during the manufacturing process.  The FDA also found the first incident was reported in 2012. Based on those dates and other information, the FDA estimated that over a half million patients may have been exposed to NTM. At the time, the Sorin 3T heater-cooler was used in roughly half of all heart surgeries performed in the U.S.

July 2017: The Lancet published a study stating that heater-cooler unit contamination with M chimaera at the LivaNova factory seems a source for cardiothoracic surgery-related severe M chimaera infections diagnosed in Switzerland, Germany, the Netherlands, the UK, the USA, and Australia.

February 2018: The Judicial Panel on Multidistrict Litigation consolidated about 40 lawsuits against LivaNova over injuries allegedly caused by their Sorin 3T heater-cooler system.

March 2019: LivaNova announced a  $225 million settlement that would resolve about 75% of the outstanding Sorin 3T lawsuits including the above MDL. Payments were made in two batches, the first in July 2019 ($135 million) and the balance in January 2020.

February 2020: The FDA issued a new Safety Communication that includes several guidelines aimed at reducing the infection risk associated with the Sorin 3T Heater-Cooler System.

November 2021:  Another lawsuit was filed against Sorin (see above lawsuits)

NTM infection Symptoms

Possible signs and symptoms of NTM infection may include:
 
fatigue
difficulty breathing
persistent cough or cough with blood
fever
pain
redness, heat, or pus at the surgical site
muscle pain
joint pain
night sweats
weight loss
abdominal pain
nausea
vomiting

If you or someone you know have undergone a cardiac procedure and are experiencing any of the signs and symptoms of NTM infection as outlined above, contact your health care provider right away. According to the CDC, there have been a total of 28 confirmed infections. The FDA reports at least 12 patients may have died as a result of the infection. And you may want to seek legal help— Open-heart surgery patients have filed 3T Heater-Cooler System lawsuits against LivaNova and Sorin Group and attorneys are currently investigating Stockert 3T Heater-Cooler System Infection complaints.
 

STOCKERT 3T INFECTION LEGAL HELP

If you or a loved one has suffered similar damages or injuries, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.

 

Last updated on Dec-7-21