The Stockert 3T Heater Cooler System has been allegedly causing mycobacterial infection reactions in patients, some of which have resulted in deaths.

The mycobacterial infection, caused by the M. chimaera bacteria, has been shown to cause serious illness and can be potentially fatal. This makes the possible correlation with the popular cardiac heater cooler all the more troubling.

Mycobacterial infection has been linked to a total of 28 patients who underwent surgery while a Stockert 3T Heater Cooler System was used, with at least 12 patients allegedly dying from the condition.

Cases of mycobacterial infection allegedly caused by the Stockert 3T Heater Cooler System have been reported in Iowa, Michigan and Pennsylvania since 2011, and remain a prevalent concern in the medical community.

Even though the mycobacterial infection is a post-surgical reaction, the FDA warns that patients can develop this reaction months or even years after their procedure.

Due to how dangerous and aggressive the mycobacterial infection is, the CDC is urging patients who had a Stockert 3T Heater Cooler System used during their surgery to seek medical attention if they experience the following symptoms:

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

The FDA and CDC have both stated that Stockert 3T Heater Cooler systems manufactured before September 2014 may have been contaminated with mycobacterium chimaera during the manufacturing process in a plant in Germany.

Mycobacterium chimaera are typically found in the ground and soil. They are ordinarily harmless, but they can be can deadly to humans under the right circumstances.

Manufacturer LivaNova PLC reportedly discovered this contamination in September 2014 when the facility was tested. The bacterial contamination was reportedly resolved by July 2015 when the facility was tested again, with the FDA stating that Stockert 3T Heater Cooler systems manufactured after September 2014 have not been linked to any infections.

Overview of Stockert 3T Cardiac Heater Cooler Mycobacterial Infection

The Stockert 3T Heater Cooler System is a heating system that is used to keep organs and blood at stable temperatures during bypass procedures, and is most popularly used for cardiac surgeries. Heater Cooler systems consist of temperature controlled water tanks which do not directly touch the patients but still present serious risks.

The FDA stated that “there is potential for contaminated water to enter other parts of the device and aerosolize,” which means that the mycobacterial particles can be transmitted through the air and can escape “through the device’s exhaust vent” and into the surrounding environment.

These particles make direct contact with the patient, which can potentially cause mycobacterial infection.

The FDA first warned against the alleged correlation between the Stockert 3T Heater Cooler System and mycobacterial infection in October 2015, but did not specifically name the device at the time. The warning stated that the agency received 32 Medical Device Reports (MDR) which described instances of deadly bacterial infections.

The FDA specified in June 2016 that the Stockert 3T Heater Cooler System was allegedly causing patients to develop mycobacterial infection. The agency provided healthcare providers with recommendations on how to contain the infection.