The makers of the Stockert 3T Heater-Cooler System, LivaNova PLC (formerly Sorin Group Deutschland), are facing heart bypass surgery infection lawsuits filed by patients alleging they suffered from serious injuries after having been infected while undergoing heart procedure.

The heart bypass surgery bacterial infection linked to the Stockert 3T heater-Cooler device allegedly results from contamination with Mycobacterium chimaera (M. chimaera), a common bacterium found in soil and water, but one that can cause serious illness for heart surgery patients.

Heater-Cooler Design

According to the FDA, heater-cooler devices are used during cardiothoracic surgeries to regulate a patient’s body temperature and improve patient outcomes.

The heater-cooler device is composed of a water tank that provides temperature-controlled water connected to warming/cooling blankets or to other surgical machines.

Potential for infection comes through bacteria transmitted through the air. The patient doesn’t ever come in contact with the water in the tank, but rather becomes contaminated through bacteria transmitted through the air through the heater-cooler’s exhaust vent.

According to the FDA, the water tanks are not completely closed off. Aerosolized M. chimaera in water droplets can escape from within the heater-cooler unit conceivably enabled by the heater-cooler devices’ fans and out through vents and into the operating room.

According to the FDA, “mycobacteria are found in much higher concentrations in water droplets emitted into the air from air bubbles rising and bursting in the tank, as comparted to the concentration of mycobacteria found in the water in the tank.”

Heart Bypass Surgery Infection FDA & CDC Warning

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have raised their concerns through safety warnings that report the Stockert 3T Heater-Cooler System has been implicated in cases of serious and life-threatening heart bypass surgery infection.

According to an FDA announcement, “through the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.”

In October 2015, an FDA announcement was made stating that it received 32 Medical Device Reports (MDRs) from patients having developed heart bypass surgery infection stemming from a heater-cooler device.

The FDA made additional warnings in June 2016 advising that M. chimaera heart bypass surgery infection could be linked to the heater-cooler device. And in October 2016, the agency further advised and sent notification letters to medical centers providing recommendations on how to avert bacterial infection risks.

The FDA says it is collaborating with heater-cooler manufacturers, public health partners, experts, and professional societies, “to evaluate additional strategies for mitigating infections associated with heater-cooler devices.”

Some of these strategies include: 1) working with health care facilities to understand their experiences working with a heater-cooler device; 2) working with infectious disease specialists to understand the causes of bacterial transmission; 3) working with the CDC to evaluated events of heater-cooler device bacterial infection; and 4) working with international public health regulatory agencies to further understanding and heighten awareness of heart bypass surgery infection risks associated with heater-cooler units.