Numerous patients have reportedly developed a potentially fatal infection after open heart surgery allegedly due to using the Sorin 3T Cardiac Heater Cooler System.

The manufacturers of this device are currently facing numerous product liability charges for allegedly failing to warn against possible infection after open heart surgery.

The FDA initially did not specify that it was the Sorin 3T Cardiac Heater Cooler system in conjunction with bacterial infection, but the agency did later confirm this in June 2016.

Previously in October 2015, the FDA reported that 32 Medical Device Reports (MDR) stated that patients may develop infection after open heart surgery and that the agency would “monitor the situation.”

Later on, the FDA identified the 3T Heater Cooler device in June 2016 as being the source of a possible M. chimaera bacterial infection after open heart surgery. These devices are manufactured by LivaNova, which discovered their cardiac heater cooler devices may have been contaminated with the M. chimaera bacteria in one of their manufacturing plants in Germany.

Both the FDA and CDC reported the manufacturing plant was contaminated with M. chimaera. The contamination was reportedly discovered in September 2014 when testing was being conducted.

While the issue was reportedly resolved in July 2015 after the facility was tested again, the FDA stated devices manufactured after September 2014 should not carry risk for contamination.

However, 3T Cardiac Heater Coolers manufactured before September 2014 may potentially induce infection after open heart surgery. A handful of patients have reportedly died from these infections already.

Overview of Infection after Open Heart Surgery

According to the CDC, there have been a total of 28 confirmed bacterial infections, with the FDA stating there had been at least 12 patients that may have died. These cases of infection after open heart surgery were reported in Iowa, Michigan, and Pennsylvania beginning in 2011 to the present.

The FDA issued its most recent warning regarding this correlation on Oct. 13, 2016. This provided healthcare facilities recommendations in preventing the infection from spreading. The FDA warns the M. chimaera infection after open heart surgery can take months or even years to develop, and that the occurrence rate is rare.

Patients who recently underwent open heart surgery using the 3T Cardiac Heater Cooler should be vigilant for any signs of infection including:

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

Cardiac heater cooler devices are used in thousands of open heart surgeries around the country. They help control the patient’s body temperature while under anesthetic. These devices consist of two temperature controlled water tanks that do not make direct contact with the patients, but may contain the deadly bacteria.

The potential for infection after open heart surgery stems from the device’s exhaust vent, which may allow for aerosolized bacteria to escape. This means the bacteria can become airborne and come into direct contact with the patient during surgery, which can result in the deadly bacterial infection.

Patients who have been impacted by these cardiac surgery infections have been filing product liability claims against LivaNova and Sorin for negligence.