Fresenius Kabi has issued a voluntary recall of the Ivenix Infusion System due to a leak in the system that allows fluid to enter the administration set loading area near the air detector. The leak damages the electrical system, leading to loss of power and failure of the system’s set sensor. Depending on the timing of the failure, this can delay or interrupt treatments.
This issue may cause interruption, under-infusion, or delays in the delivery of critical fluids, blood products, and medications.
The FDA has identified this as a Class I recall, the most serious type of recall. Fresenius Kabi has received 14 complaints related to this issue. There have been no reported injuries or deaths.
Fresenius Kabi has recalled 1,546 devices since it initiated the recall March 8, 2023, according to the FDA.
For Ivenix Infusion System model LVP-0004 devices distributed between October 27, 2021 and January 30, 2023, the company recommends the following:
- Ensure an additional and functioning large volume pump is available in treatment situations where infusion interruption could be dangerous, such as when the system is delivering life-sustaining medications, fluids, and blood products.
- 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 OR “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.
Fresenius Kabi urges customers to complete and return a response form so the company can contact them to schedule repair of affected systems and replacement if repair is not possible.