The FDA today issued a notice confirming that Getinge’s recall of certain anesthesia systems is Class I, the most serious kind.
Getinge initiated the recall of its Flow-c and Flow-e anesthesia systems (product codes 6887700 and 6887900) due to cracked or broken suction system power switches on May 2, 2022. The systems provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe and can also support the breathing of people with limited ability to do so themselves.
Affected products were distributed between June 2, 2020, and Feb. 15, 2022, according to a news release. To date, the recall has affected 64 devices in the U.S., with a total of 21 complaints, no injuries and no deaths associated with the use of the affected device, according to the notice.
The company received reports of cracked or broken on/of switches on the Flow-c and Flow-e systems’ suction unit. If the on/off switch breaks, the unit will not work to remove fluids such as phlegm, blood or stomach (gastric) content from the patient’s mouth and/or airways.
Should this issue occur, it could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. If the suction device is not working for a longer period of time, the fluids could block a patient’s breathing.
Risks associated with such a blockage may include choking, inability of oxygen to get into the blood (acute respiratory failure), an infection in the lungs that prevents oxygen from getting to the blood, brian injury caused by lack of oxygen to the brain (hypoxia) and/or death.
Getinge told users in its medical device correction letter in May that they should examine their inventory immediately to determine if any affected Flow-c and/or Flow-e anesthesia systems are in use. They can continue use of any affected devices but should perform the recommended daily system check out and pre-anesthesia checkout procedures, including checking the functionality of the suction unit.
If a cracked or broken on/off switch is found, customers should replace the machine with a fully functioning one or ensure that a temporary alternative suction substitute is available.