|Troubled Maquet’s woes continue. On the heels of a permanent injunction from the Department of Justice that resulted in the halt of manufacturing at one of its facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company’s Flow-i Anesthesia Systems have a problem that “may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”
The device is under an April recall covering 1,641 units across the globe, including 80 in the U.S. In June the recall was designated into Class 1, meaning the agency believes “there is a reasonable probability that use of the device will cause serious adverse health consequences or death.” So far, 10 instances of Flow-i malfunction have been reported, but none have led to injuries or deaths.
The FDA classifies all reported corrective action on its recall database, where it designates them into one of three categories based on severity. Occasionally, the agency also publicizes them more prominently via safety alerts.
According to a just-released alert, “The firm (Maquet) has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose. The patient cassette locking device may accidentally release the patient cassette from its mount when users perform a change of system.”
Recipients of the recall letter from Maquet are supposed to inform staff who may use the Flow-i of the patient cassette locking device issue. The company promises to replace the faulty components, whose article and serial numbers are displayed in the recall notice.
The Flow-i was also put under a Class 1 recall in 2012 due to a software issue that caused the device to switch between manual and auto ventilation modes.
Earlier this year Swedish parent company Getinge Group was in the midst of a restructuring across all three of its businesses: Infection Control (Getinge), Extended Care (ArjoHuntleigh) and Medical Systems (Maquet). In January, Alex Myers replaced Johan Malmquist, who retired, as Getinge Group President and CEO.
It appears that the new CEO still has a lot of work to do. In April the FDA announced the Class 1 recall of all 4,154 units of Maquet’s stroke-fighting TigerPaw System II left atrial appendage closure device.