The LivaNova Sorin 3T, a cardiac heater-cooler system that is used to warm or cool patients during open heart surgeries as part of their care, is being blamed for life-threatening infections.

The LivaNova Sorin 3T is used during open heart surgery to keep the blood and organs to be at proper temperatures, which tends to improve patient outcomes.

Previously made by Sorin Group Deutschland, the LivaNova Sorin 3T is now a product of LivaNova PLC.

Specifically, the LivaNova Sorin 3T, is alleged to cause the bacterial infection of Mycobacterium chimaera, a rare non-tuberculosis infection.

According to the Centers for Disease Control and Prevention, “Mycobacterium chimaera is an emerging pathogen causing disastrous infections of heart valve prostheses, vascular grafts, and disseminated infections after open-heart surgery.”

They further claim that, “growing evidence supports airborne transmission resulting from aerosolization of M. chimaera from contaminated water tanks of heater-cooler units (HCUs) that are used with extracorporeal circulation during surgery.”

The FDA says that although there is no direct contact between the surgery patient and the heater-cooler itself, “there is potential for contaminated water to enter other parts of the device and aerosolize.” The bacteria can then be transferred through the heater-cooler’s exhaust vent, circulate the room, and infect the patient.

The LivaNova Sorin 3T and other similar heater-cooler systems and devices are used on around 250,000 patients throughout open heart surgeries and bypass surgeries each year. It is estimated that the devices at issue make up roughly 60% of the heater-cooler systems used in such surgeries.

FDA Warnings Link Bacterial Infection and LivaNova Sorin 3T

It is even alleged by the FDA and CDC that these devices could have been contaminated with M. chimaera at their manufacturing facilities in Germany. According to tests conducted in September 2014, evidence of M. chimaera was located at the facility manufacturing the device.

The FDA released a communication on this issue in October 2015. The agency said it had received 32 Medical Device Reports, or MDRs, regarding patients who had allegedly contracted bacterial infections from heater-cooler systems. That communication did not identify a specific medical device but only indicated that the agency planned to “monitor the situation.”

In June 2016, the FDA issued a statement that LivaNova Sorin 3T was linked to the bacteria M. chimaera. Additionally, it had issued a warning in October 2016 to health officials with “recommendations on how to prevent the spread of infection.”

States reporting on the link between the heater-cooler system and bacterial infections include Pennsylvania, Michigan, and Iowa.

The CDC further reports that there have been 28 “confirmed infections.” And according to the FDA, 12 patient deaths may be attributable to these infections.