FDA Warning: Heart Infection Risk from Heater-Coolers

FDA Warning: Heart Infection Risk from Heater-CoolersJune 2, 2016 — The FDA has issued a Safety Communication to warn about the risk of infections that may not appear for years after patients undergo open-heart surgery in which a heater-cooler device is used.

A recently-published European study matched samples of bacteria in several infected patients with samples from the Stӧckert 3T heater-coolers.

The heater-coolers are made at a facility in Germany where the bacteria was discovered in the water supply in August 2014. Sorin implemented new cleaning and disinfection procedures in September 2014.

The bacteria is Mycobacterium chimaera, which is a type of Non-Tuberculosis Mycobacterium (NTM).

Unfortunately, the FDA has received reports of patients in the United States who were infected with M. chimaera after undergoing heart surgery involving the 3T. The agency believes infections are rare, but cautioned:

“[Infections] are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”

Heater-cooler devices use water tanks to provide temperature-controlled water that keeps patients warm or cool during cardiothoracic surgery.

Water in the devices does not directly contact the patient. However, bacteria in the water can aerosolize through the exhaust vents and land on the patient undergoing heart surgery.

Last year, the FDA warned about the risk of NTM infections after receiving 32 reports, with 25 of those reports received in 2015.

The agency asks patients who have recently undergone cardiopulmonary bypass to be aware of the symptoms of NTM infection — fatigue, trouble breathing, persistent cough, fever, pain, redness or pus at the surgical site, weight-loss, nausea, vomiting, and more.

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