A medical device company has received a warning letter over its device designed to cool patients down in a short amount of time, particularly in preparation for surgery and other clinically indicated uses. The letter said the company has not adequately responded to a malfunction in the ThermoSuit’s pump that led to a patient being overcooled to 28.5 degrees Celsius, much cooler than the 39 C on the device’s reading. Although it changed its operator’s manual to alert users to check the pump every three months rather than every six months, it failed to verify that this was an effective measure, according to the letter from the New Jersey office of the U.S. Food and Drug Administration.
