A life-saving device commonly used in heart-bypass surgeries across the nation may have been contaminated during the manufacturing process, US health regulators warned on Thursday. Some LivaNova PLC Stockert 3T heater-cooler devices may have been exposed to Mycobacterium chimaera bacteria, most likely at the manufacturing plant in Germany, the Washington Post reports. According to US News, the affected heater-cooler devices are responsible for regulating a patient's blood and organ temperature during surgery. There are around 2,000 of the devices in the US, and they're used in an estimated 60% of the 250,000 bypass procedures carried out here each year, per the CDC.
At least 28 infections have been traced back to the devices in the last year, with cases in Pennsylvania, Iowa, and Michigan, according to the Post. While the risk of this specific infection is low, especially compared to general rates of surgical infection, the CDC and FDA are attempting to inform hospitals whose patients might have been affected. The Post reports that in some cases years have elapsed before a patient was diagnosed with the infection, which can be fatal. Symptoms include night sweats, muscle aches, weight loss, fatigue, and fever.