REGULATORY UPDATE: Class I Recall Issued for Fresenius Kabi Ivenix Large Volume Pump Software

The Food and Drug Administration has issued a Class I medical device recall notice for a software correction affecting the Ivenix large volume pump (LVP) manufactured by Fresenius Kabi. The Ivenix Infusion System is indicated for controlled administration of fluids, including blood components, in hospital and outpatient settings.

The correction applies to Ivenix large-volume pump software version 5.10.1 and earlier (Product code: LVP-SW-0005). Devices remain in use and require a software update rather than product removal.

Fresenius Kabi identified two software anomalies:

• Pumps operating on battery power for extended periods may inaccurately display remaining battery capacity, potentially leading to unexpected shutdown without standard low-battery alarms.
• Entering an infusion rate with two leading zeros that exceeds drug library limits may cause the pump interface to freeze in a fail-stop alarm state.

The company stated that either issue could delay or interrupt therapy. Last year, two serious injuries related to the software anomalies were reported.

 In a Nov. 14 communication, Fresenius Kabi instructed customers to update to software version 5.10.2 after first installing Ivenix infusion management system (IMS) version 5.2.2. Until updated, facilities should keep pumps plugged into AC power when possible and avoid programming rates with two leading zeros. After installation, organizations should review battery health and replace batteries at 70% capacity or lower.