FDA Clears Water-Free Heater-Cooler Devices

5/6/22 — The FDA cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers used to warm or cool a patient during cardiopulmonary bypass procedures. 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 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. This marketing authorization reflects ongoing efforts by the FDA and industry to bring to market innovative devices that can help mitigate known adverse events related to heater-cooler devices.