Numerous patients who have recently undergone surgery using the Sorin 3T cardiac cooler device have reportedly developed infection following heart surgery.

These patients who developed infection following heart surgery often needed intense medical treatment, due to the deadly nontuberculous mycobacterium (M. chimaera) festering in the surgical site.

The Sorin 3T cardiac heater cooler device is used to control a patient’s body temperature during surgery. It consists of water tanks filled with temperature controlled water. While the water does not contact the patient directly, the FDA states there is potential for contaminated water to aerolize, putting contaminants in the air of the operating room. This significantly increases the risk of infection following heart surgery, which can potentially result in death.

Overview of Cardiac Heater Cooler Infection

Recent studies have suggested higher risks of infection following heart surgery, due to scientists finding DNA evidence indicating the bacterium to be M. chimaera.

According to a new study in The Lancet Infectious Disease, it is important for patients to understand how this alleged outbreak was discovered on the device and how it may increase the risk of infection following heart surgery.

The M. chimaera problem was discovered in patients in the United States and Switzerland who contracted these bacterial infections. Investigators discovered the bacterial infection was linked to the water in tanks used to run the device during heart surgery.

The CDC warned that the M. chimaera bacterial infections were linked to the Sorin 3T cardiac heater cooler in October 2016. The CDC discovered these devices could have been contaminated at some point during the manufacturing process. If patients were to develop infection following heart surgery, it could potentially result in fatal conditions.

Researchers had examined 24 samples extracted from 21 affected patients in Switzerland, Germany, the Netherlands, and the United Kingdom. The team compared the patient samples with samples from the LivaNova cardiac heater cooler devices, along with another German company that manufactures a similar device. The researchers found the samples from the machines had much in common with those from the patients.

LivaNova responded negatively to the study. A spokesperson for the company said the study expressed more certainty than was warranted by the data.

Ever since the M. chimaera bacterial contamination was discovered, LivaNova has been facing criticism for not warning patients at an earlier time.

The FDA issued a public safety warning regarding cardiac heater cooler infections in October 2015, stating that it had received 32 Medical Device Reports (MDR) indicating patients developed infection following heart surgery. The FDA issued a later update in June 2016, with the agency specifically identifying the 3T cardiac heater cooler devices.