Fresenius Kabi has issued a software correction for its Ivenix large-volume pump after identifying anomalies that could cause therapy interruptions or delays.
The update affects Ivenix pump software version 5.10.1 and earlier. On Feb. 25, the FDA classified the action as a Class I recall, its most serious designation, indicating the device could cause serious injury or death if the issue is not corrected.
Healthcare providers are instructed to upgrade to software version 5.10.2 and update the Infusion Management System to version 5.2.2. Temporary mitigation measures include keeping pumps plugged in during use and avoiding rate entries with two leading zeros, which can freeze the interface.
Facilities should also monitor battery health across their fleets and replace batteries below 70% capacity. The FDA said extended battery use may lead to inaccurate power readings and unexpected pump shutdowns without standard low-battery warnings. Fresenius began notifying affected customers Nov. 14.
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