The Food and Drug Administration (FDA) has issued a warning to health care providers that Maquet’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 Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with limited or no ability to breathe on their own. The system is used in hospitals, for patients ranging from neonatal to adult. In April, Maquet announced a recall of 1,641 units worldwide, including 80 in the United States. In June the recall was placed into Class 1, the most serious recall category. In a Class 1 recall, the FDA believes “there is a reasonable probability that use of the device will cause serious adverse health consequences or death.” To date, 10 instances of Flow-i malfunction have been reported, but none have led to injuries or deaths, FierceMedicalDevices reports.
According to the FDA’s July 1 safety alert, “[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 patient tubings or when the CO2 absorber is replaced. This may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.”
Maquet’s recall letter advises facilities using the system to inform staff of the Flow-i’s patient cassette locking device issue. The company will replace the faulty components, whose article and serial numbers are listed in the company’s recall notice.
The Flow-i was previously under Class 1 recall in 2012 because of a software issue that caused the device to switch between manual and auto ventilation modes. The company is under permanent injunction from the Justice Department that resulted in a halt to manufacturing at one of its facilities, the suspension of five of its devices from the market and a $6 million fine, according to FierceMedicalDevices.
For questions about the recall, hospitals should contact a Maquet Service Representative or Maquet Technical Support at 1-888-627-8383 (Press option 3, followed by option 1 and then option 1 again), Monday through Friday, from 8:00 a.m. to 5:00 p.m. EST.