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.
The letter was posted on the FDA’s website today and follows an inspection of Life Recovery Systems‘ facilities between December and January this year. The ThermoSuit has been on the market since 2006.
The U.S. regulator also took issue with the Kinnelon, New Jersey-based company’s use of a supplier to correct the temperature board malfunction and said the company was not on Life Recovery Systems’ approved supplier list. The letter said the company failed to properly evaluate the supplier before the work was carried out.
The FDA gave the company 15 days to correct the violations and explain how it plans to prevent them from happening again, or map out a timetable for how it will implement the corrections.
The device has a specially designed air mattress with a cover through which cold water is pumped. It is designed to cool a patient’s body temperature in up to 30 minutes and is seen as particularly effective in preparing patients for cardiac surgery to reduce the risk of patients suffering brain damage.
The device has also been cleared by Canadian and European regulators for temperature reduction in patients to preserve cardiac and brain functions in victims of cardiac arrest, stroke, heart attack and traumatic brain injury.
The privately held company was founded in 2003.