Getinge is recalling the Flow-c and Flow-e Anesthesia Systems after receiving reports of cracked or broken on/off switches on the system’s suction unit, according to an FDA advisory. There have been 21 complaints, no injuries and no deaths associated with the use of the products, the FDA said.
According to the agency, if the on/off switch breaks, the suction unit will not work to remove fluids such as phlegm, blood, or stomach (gastric) content from the patient’s mouth and/or airways.This issue could cause a delay during a procedure or in between procedures if the anesthesiologist needs to find another way to suction fluids. Additionally, if the suction device is not working for a longer period of time, these fluids could block a patient’s breathing.
The risks of such a blockage may include:
- Inability of oxygen to get into the blood (acute respiratory failure or ARDS)
- An infection in the lungs (pneumonia) that prevents oxygen from getting to the blood (respiratory failure)
- Brain injury caused by lack of oxygen to the brain (hypoxia)
The Getinge Flow-c and Flow-e Anesthesia Systems are intended to provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe.
The FDA reported that on May 2, 2022, Getinge USA Sales sent a Medical Device Correction letter to risk managers. The letter recommended that all customers:
- Examine inventory immediately to determine if any affected Flow-c and/or Flow-e anesthesia system(s) are in use. The serial number is found on the product label of the device.
- Continue use of any affected devices but make sure to perform the recommended daily system check out (SCO) and pre-anesthesia checkout procedures, as outlined in the Operators Manual, including:
- Check functionality of suction unit.
- If a cracked or broken on/off switch is found:
- Replace the anesthesia machine with a fully functioning one, or
- Ensure that a temporary alternative suction substitution is available.
- Complete the Medical Device Correction Response Form whether affected devices are identified or not. Return the form to the company.