The risk of heart surgery infection has become a prevalent concern for the medical community, as numerous injury reports indicate a correlation with the Sorin 3T Heater Cooler System. More specifically, there have been cases of potentially fatalheart surgery infection in conjunction with this medical device.

Models of the Sorin 3T Heater Cooler System manufactured before September 2014, may be contaminated with the nontuberculous Mycobacterium chimaera (M. chimaera). This bacteria is typically found in water or soil, but can be potentially deadly in cases of human infection.

The FDA and CDC reported the Sorin 3T Heater Cooler System may have been contaminated during the manufacturing process in Germany, after testing found presence of M. chimaera bacteria in September 2014.

The contamination was reportedly resolved in July 2015 when the facility was retested, with the agency stating the risk of heart surgery infection should not be present in devices manufactured after September 2014.

While the risk for heart surgery infection is still a problem, the FDA states developing the M. chimaera infection is very unlikely and is a rare occurrence. However, it should be noted this infection can take months or even years to develop after heart surgery, so patients and doctors should be vigilant for any signs of late onset infection including:

• Night Sweats
• Muscle Aches
• Joint Pain
• Weight Loss
• Fatigue
• Unexplained Fever
• Fatigue

This potentially fatal heart surgery infection has been reported in Iowa, Michigan, and Pennsylvania from early 2011 to present.

According to the CDC, there have been approximately 28 confirmed cases of heart surgery infection, with the FDA stating there had been at least 12 deaths. Over the last few years, the FDA and CDC have issued several warnings regarding the serious risk of heart surgery infection.

Overview of Heart Surgery Infection

The FDA issued the first safety warning in October 2015, stating there had been 32 related Medical Device Reports (MDR) submitted to the agency. These injury reports alleged a cardiac heater cooler device may be linked to potentially deadly heart surgery infection, but did not specify the Sorin 3T Cardiac Heater Cooler at the time.

The agency released another warning in June 2016, with the agency linking the M. chimaera infections linked to LivaNova’s 3T cardiac heater cooler devices. The most recent warning was released by the FDA in Oct. 2016, which provided health officials instructions on how to prevent heart surgery infection from spreading.

The Sorin 3T Heater Cooler System is a popular medical device often used in open heart surgeries to control the body temperature of patients while under anesthesia. The medical device consists of temperature controlled water tanks, which do not actually touch the patient.

However, the FDA stated there was “potential for contaminated water to enter other parts of the device and aerosolize” through the device’s exhaust vent. This allows for bacterial cells to become airborne, and come into direct contact with the patient and surgical site.

Patients who developed the deadly heart surgery infection after the Sorin 3T Heater Cooler System is used may be able to file legal action.