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# FDA Update on Heater-Cooler Devices
- URL: https://www.fdaweb.com/fda-update-on-heater-cooler-devices/
- Published: 2022-06-14T12:00:00.000Z
- Updated: 2026-09-14T17:48:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152066

FDA has provided an [update](https://www.fda.gov/medical-devices/what-heater-cooler-device/fdas-ongoing-evaluation-and-continued-monitoring-reports-nontuberculous-mycobacteria-infections?utm%5Fmedium=email&utm%5Fsource=govdelivery#design) on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections in patients who have undergone cardiothoracic surgery using the devices. The agency says that last month it cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers. “Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to ultimately regulate the temperature of a patient’s circulating blood,” the update says. “The Quantum Heater-Cooler's HTF demonstrated it mitigates the risk of contamination of the device by suppressing the growth of nontuberculous mycobacteria and other bacteria.”