This warning from the FDA comes as part of its Communications Pilot to Enhance the Medical Device Recall Program. The agency became aware of a potentially high-risk device issue and plans to keep the public informed on the issue.
On Dec. 5, Fresenius Kabi USA sent all affected customers a letter recommending product removal until repaired. It covers the Ivenix large-volume pump (LVP) 0004 and the system’s pneumatic valve. Customers should remove and isolate all affected products. If not feasible, they should proceed with caution and ensure the availability of another LVP for situations where infusion interruption could be dangerous.
The company reports that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm. Customers should remove all devices with affected valves, evaluate them and return them to Fresenius Kabi’s facility for repair.
If the pneumatic valve fails, the company says it spurs a “Pump Problem” alarm. If this occurs during LVP setup, it could delay therapy. If it occurs during an active infusion and interrupts flow, it could lead to underdosing. The FDA says delay or interruption of a life-sustaining infusion may result in permanent disability or death.
According to the FDA and Fresenius Kabi, the pump problem alarms work as intended. They arise indicating when to act if a malfunction occurs. Fresenius Kabi reports no injuries or deaths related to the issue.
This marks the latest stumbling block for the Ivenix system. The FDA identified a serious recall of Ivenix infusion pump administration sets in September. Fresenius Kabi’s Ivenix infusion system faced a software recall earlier this year, too.
