Patients who have suffered from infection following heart surgery have been filing lawsuits against the manufacturers of the Stockert 3T Heater-Cooler System, LivaNova PLC.

The infection following heart surgery linked to the Stockert 3T Heater-Cooler device is a non-tuberculous bacterial infection called Mycobacterium chimaera.

Although the bacteria can be the cause of serious illness or even death, it is often found in the environment, such as soil and water, and rarely makes people sick.

FDA/CDC Warning: Infection Following Heart Surgery

Both the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have warned of infection following heart surgery that has been linked to the Stockert 3T Heater-Cooler system.

The Stockert 3T Heater-Cooler System is considered an important device used during heart surgeries as the device works to keep a patient’s blood and organs at regulated temperatures during procedures.

According to an FDA announcement, “[t]hrough the FDA’s analysis of adverse event reports, the medical literature, and information from national and international public health agencies, we are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures.”

An NTM bacteria is known to grow in the water tank of the heater-cooler unit. Although the patient does not come in direct contact with the water in the heater-cooler unit, potential for infection following heart surgery can result from contaminated water that disperses through the device’s vent or other openings outside the water tank into the operating room.

According to the FDA, there is a much higher concentration of mycobacteria in water droplets emitted through the air from within the tank’s vents and openings than the concentration of mycobacteria found within the tank itself. NTM bacteria found in water droplets remain suspended in the air, thus increasing the likelihood of infection following heart surgery.

This greatly increases the chance of “entering the patients open surgical cavity or contaminating a sterile implant such as a heart valve”, the FDA reports.

In October 2015, the FDA reported that it received 32 Medical Device Reports (MDR) from patients who developed infections following heart surgery directly caused by heater-cooler devices.

The FDA, in June 2016, further announced that the Stockert 3T heater cooler device manufactured by LivaNova PLC was linked to M. chimaera infections, and the FDA issued its most recent warning on Oct. 13, 2016 notifying medical centers on how to avert the risks of bacterial infection following heart surgery or other procedures.

According to the CDC, patients should be on the lookout if they are experiencing symptoms associated with an infection following heart surgery such as night sweats, muscle aches, weight loss, unexplained fever, and fatigue.

The CDC states that more than 250,000 heart bypass procedures are performed using heater-cooler units in the United States every year.

According to the CDC, it estimates that “in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.”