Class 1 Recall: FLOW-i Anesthesia Systems - Dislodged Patient Cassette May Stop Patient Ventilation
The firm has received several complaints where patient cassettes, which are the center of gas flow in the system, have come loose.
Fri Jul 17 2015
Recall Class: Class I
Date Recall Initiated: April 2, 2015
Device: FLOW-i Anesthesia Systems
- Article Numbers: 66 77 200, 66 77 300, 66 77 400
- Manufacturing and Distribution Dates: July 7, 2011 to May 5, 2014
- Number of Units Distributed in the U.S.: 69
Use: 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.
Recalling Firm: Maquet Critical Care AB
Rontgenvagen 2
Solna SE-171 54
Sweden
Reason for Recall: 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 deaths have been reported.