Heart surgery bacterial infection has been reported in conjunction with the 3T Heater Cooler Systems, with several deaths already reported.

According to the CDC, there have been approximately 28 cases of heart surgery bacterial infection — including at least 12 deaths, according to the FDA.

Both agencies warn that these bacterial infections do not always develop immediately. Some patients report the infection developed months or years after their surgery. This can prevent patients and doctors from immediate diagnosis, which allows the infection to progress and increases the chances of fatality.

Cardiac heater cooler systems are used to help keep a patient’s body temperature under control during open heart surgery while the patient is under anesthesia. This device consists of an exhaust vent and two temperature controlled water tanks. The water does not directly contact the patients in any way.

However, it has been reported that some 3T heater cooler devices may have been contaminated during manufacturing and may release deadly bacteria into the surgical environments at some hospitals.

This puts the patient at risk for potentially deadly heart surgery bacterial infection, with the Stockert 3T Heater Cooler System linked to reported instances of infection. According to the FDA, these bacterial cells can potentially aerosolize through the exhaust vent and make direct contact with the patient’s surgical site.

Overview of Heart Surgery Bacterial Infection

The bacterium reported in conjunction with this deadly heart surgery bacterial infection is the nontuberculous strain Mycobacterium chimaera (M. chimaera) bacteria.

The bacteria was discovered during testing in 2014 in the Stockert manufacturing plant in Germany. While this problem was reportedly resolved by July 2015 when the facility was retested, the FDA stated that the risk for heart surgery bacterial infection is not prevalent in devices manufactured after September 2014.

The FDA officially reported that LivaNova’s Stockert 3T Heater Cooler System was linked to M. chimaera bacterial infections in June 2016. The FDA previously stated that it had received 32 Medical Device Reports regarding cases of heart surgery bacterial infection in October 2015.

At the time, the FDA did not name any specific medical devices and that it would “monitor the situation.” The most recent warning from the FDA was announced on Oct. 13, 2016, which provided health officials with recommendations on how to prevent heart surgery bacterial infection.

The agency further stated the M. chimaera bacterial infection was rare, and it could take months or years for infection to show symptoms. Patients who recently underwent open heart surgery using the 3T cardiac heater cooler medical device should be vigilant for any signs of infection including:

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

If allowed to progress, the heart surgery bacterial infection can be potentially fatal and should be reported to a medical professional as soon as possible. Even though this can be potentially fatal to patients, some patients claim LivaNova PLC and Sorin Group allegedly failed to to warn patients and the medical community after the bacterial contamination was discovered.

Recent open heart surgery patients should be vigilant against any signs of infection, especially if a cardiac heater cooler was used during their procedure.