FDA Warns of Heater-Cooler Device Infection Risks

The FDA has expressed concerns about the risk of infections associated with CardioQuip’s modular heater-cooler device.

Three patients from one U.S. facility were infected with Mycobacterium abscessus after undergoing cardiothoracic surgery involving the use of a CardioQuip Modular Cooler-Heater, the agency warned. Previously, the FDA had not received reports of nontuberculous mycobacteria (NTM) patient infection or NTM device contamination with use of the device.

“At this time, the root cause of NTM patient infection and device contamination with use of this device is not known,” the agency said, adding that “NTM patient infections, NTM device contamination and, in some cases, both issues have now been reported for all manufacturers of heater-cooler devices in the United States.”