A&G represents consumers injured by the Stöckert 3T, a medical device which we believe exposed thousands of patients to dangerous and deadly bacterial infections during the course of heart-bypass and other open-chest surgeries. If you or a loved one suffered a bacterial infection after undergoing this type of surgery between 2007 and 2017, we want to hear from you.
What is the Stöckert 3T?
The Stöckert 3T is a temperature control device that utilizes an internal water supply to provide heating and cooling to patients in surgery through various accessories, such as heating/cooling blankets, heart paralysis heat exchangers, and oxygenator heat exchangers.
The Stöckert 3T was primarily manufactured in München, Germany by Sorin Group Deutschland GmbH starting in 2006. Sorin Group and Colorado-based Sorin USA were acquired by LivaNova PLC in 2015. LivaNova PLC is based in London, UK, and trades publically on the NASDAQ stock exchange.
Information from the Federal Drug Administration (FDA) and other sources indicate that Stöckert 3T internal water tanks were manufactured with dangerous levels of a microbial agent present; specifically, Mycobacterium Chimaera (M.Chimaera). Testing conducted by Sorin in August 2014 found M. Chimaera contamination on the production line and water supply at the Stöckert 3T manufacturing facility in Germany. The Stöckert 3T devices manufactured at this facility were distributed worldwide.
When Stöckert 3T devices heated water during heart-bypass and other open-chest surgeries, we believe these bacteria aerosolized (vaporized/spread through the air) and infected highly compromised patients under general anesthesia. Several deaths have been linked to the aerosolization of M. Chimaera by the Stöckert 3T, and the FDA is currently investigating dozens of Medical Device Reports of patient infections from the United States and Europe.
Diagnosis and Symptoms of M. Chimaera:
Chimaera, characterized as a nontuberculous mycobacterium (NTM), is a slow-growing bacterium that can cause serious illness or death. M. Chimaera infections are difficult to detect because infected patients may not develop symptoms or signs of infection for months to years after initial exposure. This extended time period makes it particularly hard for physicians to pinpoint Stöckert 3T devices as the source of a patient’s infection and for patients to associate the symptoms they experience with the surgery they had years prior.
Symptoms of M. Chimaera infection include, but are not limited to:
- Heat/warmth and/or pus around a surgical incision
- Night sweats
- Joint Pain
- Muscle Pain
The FDA’s Response:
Between July 15, 2015, and July 25, 2017, the FDA issued 14 specific product recalls for various models of the Stöckert 3T. The FDA also published several safety communications to hospitals, physicians, and the general public warning them of the potential dangers of Stöckert 3T devices.
On December 29, 2015, the FDA issued a warning letter to LivaNova after inspections conducted at its Stöckert 3T facilities in Colorado and Germany revealed violations of federal good manufacturing practice regulations. Since the Stöckert 3T is manufactured in Germany, it is under restricted import until the violations are corrected.
The Manufacturer’s Response:
LivaNova and its Sorin subsidiaries have instituted new cleaning and care protocols for the Stöckert 3T. The company has moved forward in its manufacturing process, making new Stöckert 3T devices with higher grade components than earlier models. Only time will tell whether these measures will stop future patient infections.