FDA Warns Heart Surgery Patients at Risk for Serious Infection
The U.S. Food and Drug Administration advised health care providers of a recent outbreak of infections in heart surgery patients. This letter was sent after three patients at one U.S. facility were infected with Mycobacterium abscessus — a type of Nontuberculous mycobacteria (NTM) — after undergoing cardiothoracic surgery involving the use of a CardioQuip Modular Cooler-Heater. These devices are used to regulate blood temperature during open-heart surgery.
The FDA stated in the letter to healthcare providers that it as been monitoring the risk of NTM infections in heart surgery patients and noted that device contamination may be a cause of these infections. NTM patient infections and NTM device contamination have now been reported for all manufacturers of heater-cooler devices in the United States.
NTM infections may take months to develop in open-heart surgery patients. Symptoms may include night sweats, muscle aches, weight loss, fatigue, or unexplained fever. After initial reports of NTM infections were reported to the FDA related to the Stockert 3T heater cooler, the agency recommended that patients who have undergone any type of cardiothoracic surgery and have experienced any of the signs and symptoms of an NTM infection to promptly contact their health care provider.
If you or someone you know had open-heart surgery and developed an infection, contact us. Our personal injury attorneys have experience litigating thousands of claims against medical device manufacturers and can advise you of your legal rights and options.
