Dive Brief:
- Getinge’s May 2 recall of anesthesia machines has been labeled a Class I event by the Food and Drug Administration due to the risk of patients dying or being seriously injured.
- The company is recalling Flow-c and Flow-e Anesthesia Systems after receiving reports of cracked or broken on/off switches on the machine’s suction unit.
- The recall affects 64 devices in the U.S. Getinge has received 21 complaints regarding the issue, but it has not received any reports of patient injuries or death. The latest Class I recall is Getinge’s fifth since September, including ones involving its subsidiaries Atrium Medical and Datascope.
Dive Insight:
The Flow-c and Flow-e Anesthesia systems are used to provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe. The machines, which are for patients ranging from newborns to adults, are also used for patients who cannot breathe on their own.
According to the FDA’s notice, if the device’s on/off switch breaks, the suction unit will not remove fluids like phlegm, blood or stomach contents from patients’ mouths or airways. Along with potentially delaying procedures, broken suction systems can cause fluids to block patients’ breathing and potentially lead to choking, inability to get oxygen into the blood, lung infection, or brain injury caused by lack of oxygen, and death, the FDA wrote.
Getinge, based in Gothenburg, Sweden, sent a recall letter to customers on May 2, advising them to immediately check inventory for affected machines, the FDA said. The company asked users of the affected devices to check the functionality of the suction unit and to replace anesthesia machines if they find a cracked or broken switch.
The recall affects devices distributed from June 2, 2020, to February 15, 2022.
Getinge has recently had four other Class I recalls. In March, its subsidiary Atrium Medical recalled nearly 69,000 stents due to the separation of the balloon or catheter hub during the removal of the delivery system from the patient. The recall was linked to 75 complaints and nine injuries.
In December, Getinge recalled a component of Maquet anesthesia gas machines due to the risk of “harmful chemical exposure.” In October, the company recalled heart balloon pump devices after reports of one patient death and 71 complaints, and in September, it recalled battery packs for those devices.
The FDA’s recall database named the recalling firm for the September and October recalls as Datascope, which Getinge acquired in 2008.
