The manufacturer of the Stockert 3T Heater-Cooler System is facing products liability litigation pertaining to allegations that the system causes the contraction of life-threatening infections after the system has been used during heart surgery procedures.

According to reports, open-chest surgery infection has been associated with the Stockert 3T Heater-Cooler device. Allegedly, the open-chest surgery infection that is being contracted is a bacterial infection known as Mycobacterium chimaera. This contraction of open-chest surgery infection has led to purported deaths and serious illnesses.

The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have reportedly also issued warnings pertaining to open-chest surgery infection that may be contracted after contact with the Stockert 3T Heater-Cooler system.

The Stockert 3T Heater-Cooler System is manufactured by LivaNova PLC. The system helps keep a patient’s blood and organ temperature at proper levels during heart or bypass procedures.

What occurs, however, with the open-chest surgery infection is that the temperature of water in a tank is controlled at specific levels. This temperature-controlled water helps regulate the temperature of the patient.

However, if the water tank has not been cleaned out properly, or cleaned out at all, the bacteria can colonize and grow within the tank and can become transmitted through the air through the tank’s vents.

According to the FDA, “there is potential for contaminated water to enter other parts of the device and aerosolize,” meaning that the bacteria is transmitted in the air and “through the device’s exhaust vent into the environment and to the patient.”

According to reports, there are roughly 250,000 open heart surgeries every year. Additionally, reports maintain that roughly 60% of these devices have been associated with open-chest surgery infections in hospitals and medical facilities throughout the country.

Reports are further maintaining that the Stockert 3T heater-cooler devices may have been contaminated with Mycobacterium chimaera in their manufacturing facility in Germany. During a test at the manufacturing facility in September 2014, the bacterial infection was found where the product was being manufactured.

However, following another test in July 2015, the U.S. Food and Drug Administration announced that the issue was resolved, and that open-chest surgery infection has not been linked to any 3T devices manufactured after September 2014.

In a safety communication issued by the FDA in October 2015, the agency said 32 Medical Device Reports, or MDRs associating patients who have allegedly developed open-chest surgery infection or other alleged infections, were purportedly linked to the 3T heater-cooler device. Thereafter, the FDA mentioned only that the planned to “monitor the situation.”

In June 2016, the FDA reported alleged links between the 3T heater-cooler system and M. chimaera infections, or open-chest surgery infection, and in October 2016 they also issued an announcement to health officials of recommendations in how to prevent the spread of the bacterial infection and to stop alleged open-chest surgery infection.