The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Flow-c and Flow-e Anesthesia Systems
- Product Codes: 6887700, 6887900
- Product Serial Numbers: See Recall Database Entries
- Devices Recalled in the U.S.: 64
- Dates distributed: June 2, 2020, to February 15, 2022
- Date Initiated by Firm: May 2, 2022
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. These systems can also support the breathing of people with limited ability to do so themselves.
It is used for patients ranging in age from newborns (neonatal) to adults and operated by trained anesthesiologists in hospital settings.
Reason for Recall
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. 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)
There have been 21 complaints, no injuries and no deaths associated with the use of this device.
Who May Be Affected
- Health care personnel who use the Flow-c or Flow-e Anesthesia System with patients in health care settings.
- People who are treated in a health care setting using the Flow-c or Flow-e Anesthesia System.
What to Do
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. Email the form to: firstname.lastname@example.org or fax to (877) 548-4901.
Be aware, Getinge service representatives will contact affected customers to schedule on-site correction of the device. Customers can also schedule a visit from a Getinge trained or authorized service technician by contacting Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between 8 am and 6 pm (Eastern Time Zone).
Customers with questions or concerns about this recall should contact Getinge Customer Technical Support at (888) 9GETUSA / (888) 943 8872 (select option 1, then option 2), Monday through Friday, between 8 am and 6 pm (Eastern Time Zone).
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.