ISSUE: FDA is providing notification of a Class I recall of FLOW-i Anesthesia Systems by Maquet. The firm 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.
The firm has received 10 foreign reports this device has malfunctioned; no injuries or deathshave been reported.
BACKGROUND: The Flow-i Anesthesia System administers anesthesia while providing ventilation to patients with no or limited ability to breathe. The system is used in hospitals, for use in a range of patients from neonatal to adult.
RECOMMENDATION: A Maquet Service representative will contact consignees to arrange replacement of the FLOW-i Anesthesia System patient cassette locking device.
For questions regarding this field action, please 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, between the hours of 8:00 a.m. and 5:00 p.m. EST.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information
and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/01/2015 -Recall Notice - FDA]