The FDA this week said the Fresenius Kabi recall of some Ivenix infusion systems is Class I, the most serious kind.
Fresenius Kabi is recalling some Ivenix infusion systems due to a leak in the system that allows fluid to enter the administration set loading area near the air detector.
The leak could damage the electrical system and result in a loss of power and failure of the system’s set identification sensor, which can delay or interrupt treatments. This issue may cause serious injury or death to patients due to interruption, under-infusion or delays in the delivery of critical fluids, blood products and medication, according to an FDA notice.
Fresenius Kabi has received 14 complaints related to this issue. There have been no reported injuries or deaths.
There are 1,546 devices involved in the recalls, which were distributed October 27, 2021 to January 30, 2023.
The Ivenix Infusion System is a high-capacity pump used in hospitals and other healthcare facilities to administer fluids to patients in precisely controlled infusion amounts and rates. The system dispenses blood or blood products, medications and other fluid blends through veins, the epidural space in the back or subcutaneously beneath the skin. It is employed for both adult and pediatric patients, including neonates, infants, children, and adolescents.
Recommendations from the company
Fresenius Kabi sent an urgent medical device recall letter to customers on March 10, 2023 and recommended the following actions.
- In situations where infusion interruption could be dangerous, such as when the system is administering life-sustaining medications, fluids and blood products, it is crucial to ensure the availability of an additional and operational high-capacity pump for treatment purposes.
- Use a different large volume pump if unable to start or resume an infusion based on provided instructions.
- Take notice of functioning alarms and alerts.
- Avoid fluid buildup at the Air Detector and wipe any liquid off the Air Detector areas after cleaning and disinfection, or if a spill occurs on the pump, per the Instructions For Use (IFU).
- Inspect the Air Detector to ensure there is not fluid present or visible fluid spots on the surface of the Air Detector if the pump shows:
- “Reload Cassette” alert during set up.
- “Tubing Set Removed” audible and visual alarm during use.
- Report persistent “Reload Cassette” alerts and any failures of the pump to recognize the administration set after re-insertion to biomedical engineers and use another pump.
- Remove Ivenix Infusion Systems from use and contact Fresenius Kabi if “Reload Cassette” alerts or “Tubing Set Removed” alarms continue after biomedical engineers inspect and re-clean the Air Detector area of the system.
- Consider posting these recommended steps at each nursing station.