The FDA is warning healthcare providers of a potential infection risk linked to heater-cooler devices used during cardiothoracic surgery.
The agency received three reports of patients from one healthcare facility who were infected with Mycobacterium abscessus bacteria after heart surgery involving CardioQuip's Modular Cooler-Heater. The bacteria typically do not pose a threat to humans, but in rare cases can cause infections or death. The cause of the infections and device contamination is unknown, the FDA said.
While the FDA first highlighted the risk of infection involving heater-cooler devices in 2015, these cases mark the first reported infections linked to CardioQuip's device. The agency has received reports of patient infections or device contamination from every U.S. manufacturer of the devices.
"While the FDA believes that NTM infections in patients who have undergone cardiothoracic surgery with use of a heater-cooler device are rare, healthcare providers and users should be aware that these NTM infections can and do occur," the agency said.
To view the FDA's recommendations to reduce infection risk linked to the devices, click here.