CardioQuip Cooler/Heater Tied to Infections

FDA says its ongoing evaluation of the risk of Nontuberculosis mycobacteria (NTM) infections in patients who undergo cardiothoracic surgery using heater-cooler devices has found three U.S. patients from one facility who were infected with Mycobacterium abcessus (a type of NTM) after undergoing cardiothoracic surgery involving the use of a CardioQuip Modular Cooler-Heater. An agency online statement says FDA had not previously received reports of patient infection or device contamination with the CardioQuip device.

“At this time, the root cause of NTM patient infection and device contamination with the use of this device is not known,” the statement says. “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 U.S.”

The statement includes recommendations for healthcare providers to help reduce the risk of NTM infections in patients undergoing cardiothoracic surgeries.