If you contracted an M. chimaera infection after undergoing open heart surgery, a contaminated heater cooler device may be the bacteria’s source.

The Stockert 3T Heater Cooler System is made by LivaNova PLC, formerly known as Sorin Group Deutschland. The device is sometimes known by its former name, the Sorin 3T Heater Cooler.

The heater cooler keeps a patient’s blood and organs within a normal temperature range during open heart surgery. Unfortunately, the positive impact of this vital role has been tarnished by the fact that some of the German-made Stockert 3T heater coolers manufactured before 2015 could have been contaminated with M. chimaera bacteria.

The Center for Disease Control and Prevention estimates 60 percent of the open heart bypass surgeries performed in 2016 used the Stockert 3T to regulate blood and organ temperature, potentially placing 150,000 patients at risk of M. chimaera infection.

At least 15 U.S. patients have died, because M. chimaera can become resistant to commonly used antibiotics. The M. chimaera infection can start in the inner lining of the heart and then spread to other parts of the body.

U.S. patients who received open heart surgery prior to 2014 should be aware of symptoms of a possible M. chimaera infection, which can take months or years to develop. Night sweats, muscle aches, weight loss, fatigue, unexplained fever, or pus developing around the incision site are indications of a possible M. chimaera infection.

M. Chimaera Infection Traced to 3T Facility

The Lancet Infectious Diseases Journal published a study last summer that traced the M. chimaera infection source to a manufacturing plant in Munich, Germany. The Stockert 3T heater coolers were almost certainly contaminated there because scientists matched the bacteria’s DNA from infected patients with samples found in the factories.

M. chimaera bacteria naturally occur in soil and water, and no one is sure how the strain entered the 3T heater coolers.

Even though blood and organs do not come in physical contact with the machines during use, the 3T heater cooler can emit a mist that enters the air while the device is in use. Contaminated particles may float through the air and can land in the open chest cavity of the patient.

To prevent new patients from becoming ill, the FDA issued new guidelines to clean and care for the 3T heater coolers in October 2016. The FDA has advised doctors to use new accessories, connectors and tubing with the devices. The machine’s exhaust fan should be directed away from the patient to ensure the mist is carried away from the open chest cavity.

At least one hospital has opted to place the heater cooler in a separate room in an effort to ensure sterility in the operating room.

The Centers for Disease Control and Prevention notes that even though thousands of patients have been alerted that they could have been exposed to bacteria that could result in M. chimaera infection after heart surgery, the number of exposed patients could be much higher.