The FDA has notified health care professionals about a Class I recall of Maquet's FLOW-i Anesthesia System, due to complaints of a dislodged part preventing ventilation.
The FDA has notified health care professionals about a Class I recall of Maquet’s FLOW-i Anesthesia System, due to complaints of a dislodged part preventing ventilation.
Hospitals use the system to administer anesthesia while providing ventilation to a variety of patients ranging from neonates to older adults who have limited or no ability to breathe.
Maquet has received several complaints about the system’s patient cassettes, which are center of anesthesia gas flow, coming loose from their mounts when users change patient tubings or replace the carbon dioxide absorber. This may cause the gas to leak and prevent the ventilator from providing breathing support.
The manufacturer has received 10 reports of device malfunctions thus far, but no related deaths or injuries have been reported.
Maquet said its representatives will arrange replacement of the recalled system’s patient cassette locking device for consignees. In addition, the FDA is encouraging health care professionals and patients to report any related adverse effects to its MedWatch Safety Information and Adverse Event Reporting program.