The Sorin Stockert 3T Heater Cooler system, sometimes called the Sorin 3T Heater Cooler system, has been allegedly causing patients to develop deadly bacterial infections after undergoing open heart surgeries.

The Sorin Stockert 3T Heater Cooler system allegedly allowed M. chimaera bacterial infections to develop in the patients. Investigators believe the devices could have been contaminated during their manufacturing process.

The Sorin Stockert 3T Heater Cooler has been linked to rare nontuberculous mycobacteria infections in patients, which can result in potentially fatal illness and death.  The Sorin Stockert 3T Heater Cooler has safety warnings issued by both the FDA and CDC, warning the public this device is linked to fatal bacterial infections.

The health agencies go further to say that that the M. chimera bacteria may have contaminated a number of these devices while being manufactured in Germany, based on testing conducted in September 2014. This problem was supposedly resolved in July 2015, when the manufacturing facility tested negative for bacterial contamination.

However, the new test results did not help patients who already underwent open heart surgery using allegedly contaminated Sorin Stockert 3T Heater Cooler, and later developed bacterial infections.

The FDA had issued a public warning in October 2015, when the agency received 32 injury reports indicating patients developed deadly bacterial infections after undergoing surgery that used heater cooler devices.

At this time the FDA did not specifically name the Sorin Stockert 3T Heater Cooler during its 2015 warning. The agency later identified the device in June 2016 after learning these devices were linked to M. chimaera bacteria.

Overview of Sorin Stockert 3T Bacteria Infection Complications

The Sorin Stockert 3T Heater Cooler is manufactured by LivaNova PLC, and is considered a vital device in the medical community. This heater cooler devices are used in over 250,000 open heart surgeries and bypass surgeries every year, with about 60% of those devices linked to potentially deadly infections.

The Sorin Stockert 3T Heater Cooler is one of the most popular heater cooler devices, which are used to keep organs and blood at ideal temperatures during the patients’ surgical procedures.

This device consists of water tanks with the liquid kept at strictly controlled temperatures to keep the patients from getting too cold. While the water does not touch the patient directly, the FDA warned “there is potential for contaminated water to enter other parts of the device and aerosolize.”

This means the bacteria can enter into the air through the device’s exhaust vent, possibly resulting in direct contact with the patient. According to the FDA, at least 12 patients have died as a result of cardiac surgery bacterial infections.

The FDA and CDC warn the infection can take a while for symptoms to develop, sometimes months or even years. Patients who underwent recent heart surgeries are encouraged to seek medical attention if they experience sudden fever and severe fatigue.

Patients who underwent heart surgery using the Sorin Stockert 3T Heater Cooler device and later developed infection may be able to file legal action against the manufacturer.