Post-op heart surgery patients who experience night sweats, muscle aches, weight loss, fatigue, or unexplained fever should contact their doctors, stat, federal officials say. They’re warning that a medical device, designed to keep organs and blood at a constant temperature, was contaminated with nontuberculous mycobacterium (NTM). Officials already have confirmed more than two dozen NTM infections in open heart patients, and thousands more may be at risk.
The federal Centers for Disease Control and Prevention flagged the potential patient risks linked to the Stöckert 3T, temperature-regulating surgical devices made by LivaNova PLC (formerly Sorin Group Deutschland GmbH).
Temperature-regulating devices are common in the 250,000 open heart surgeries performed annually in hospitals, officials say, and 60 percent of the procedures involve the German-made model. NTM infections may not develop immediately, and some cases were confirmed as many as four years after surgery. They typically are not fatal but can be problematic for immune-compromised patients, such as many open heart patients are. They respond well to antibiotics if detected.