Sorin Stockert 3T Heater-cooler
The Sorin Stockert 3T heater-cooler is a device manufactured by LivaNova, a medical device company formed by the merger of Cyberonics and Sorin S.p.a. in 2015. The Stockert 3T device uses three tanks to circulate both heated and cooled water during invasive surgical procedures. The circulated water is used to both keep patients warm and cool the heart during a cardioplegia surgery which involves temporary stoppage of the heart.
The tanks of the 3T device have been found to encourage bacterial growth which may increase the risk of serious infections in vulnerable patients.
Stockert 3T Contamination
One particular type of bacteria, Mycobacterium chimaera, has been frequently been found growing in the tanks of the Stockert 3T surgical device. M. chimaera is one species of the same type of bacteria which causes tuberculosis. Though M. chimaera does not normally pose a serious health risk to healthy people, those undergoing open-heart or other invasive chest or abdominal surgery are at risk of a fatal infection posed by the Stockert device.
During a procedure, water or fluid in the Sorin Stockert device, is vaporized and emitted as steam under certain conditions. If the tanks of the 3T device have become contaminated, infected vapor containing bacteria may be spread into a previously sterile surgical suite. This may present a high risk of infection of vulnerable.
Twelve deaths and 79 serious infection events were reported the U.S. Food and Drug Administration between 2010 and 2016. An investigation by health authorities in the European Union have found that contamination may have 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.
In addition, the company has been cited for failing to provide adequate procedures or information about the need for cleaning and disinfecting.
Stockert 3T Heater-Cooler FDA Warnings
Even before the EU investigation found a link between bacterial strains infecting patients and bacterial strains at manufacturing facilities, the FDA has issued a number of warnings against LivaNova, the Stockert’s manufacturer. LivaNova was accused of failing to conform with “good manufacturing practices” or GMP in manufacturing, packaging and storage facilities. The company was informed that the devices may be subject to a nationwide ban if contamination events were not adequately addressed. The FDA warned that the Stockert 3T devices could be designated as “adulterated” or “misbranded” products which would prevent their sale or use in the U.S.
After the discoveries of contamination links to German manufacturing facilities were discovered by EU health authorities, a recall was issued in June of 2015. Recall information stated that there was a high risk of potential colonization and spread of bacteria if adequate maintenance and disinfection was not performed.
Sorin Stockert 3T M. chimaera Infection Risk
In the U.S., an estimated 250, 000 cardiac bypass surgeries are performed every year. About 60% of these invasive surgeries utilize a Stockert 3T unit. Between 2010 and 2016, 12 deaths were reported but up to 500,000 patients were potentially placed at risk.
Once exposed to M. chimaera in the operating room, experts estimate that there is a 1 in 100 to a 1 in 1000 chance of developing infection. If infection occurs, M. chimaera may be fatal up to 50% of the time, even with aggressive antibiotic treatment. Those who have heart valves or other prosthetics implanted during an exposure event are at greatest risk.
Unfortunately, due to the type of infection, it may take months or years for signs and symptoms of disease to occur and infection may go unrecognized until too late for intervention to be successful.
After the 2015 FDA recall of the device, the U.S. Centers for Disease Control and Prevention (CDC) issued an information packet and toolkit to healthcare practitioners and facilities which helps doctors to identify infections.
Symptoms of infection include:
- Muscle aches
- Night sweats
- Weight loss
- Chronic cough
- Inflammation of Lymph nodes
- Abdominal abscess
- Drainage from wound
In June of 2016, the FDA issued a safety alert warning healthcare providers and facilities about the high risk of infection associated with the Soring Stockert 3T units. Later the same year, in October of 20106, the Agency recommended that facilities replace older units which may be contaminated with newer units as soon as possible.
Stockert 3T Infection Lawsuits
LivaNova is facing a number of Stockert 3T lawsuits in federal and state courts. Federal Stockert lawsuits have been consolidated into (MDL) in the U.S. District Court for the Middle District of Pennsylvania but no announcements have been made as to trial or settlement dates. People or loved ones of those who suffered complications after a Stockert 3T surgery should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.