Fresenius Kabi Issues Letter About High-Risk Issue With Infusion System Software

Fresenius Kabi USA has issued a letter to “affected healthcare providers recommending certain software versions of the Ivenix Infusion System be updated related to a potentially high-risk device issue.” The FDA has the release.

The specific software version affected is the “Large Volume Pump (LVP) Software, version 5.9.2 and earlier.” The letter recommends that customers “update the LVP software to version 5.10” and provide instructions on how to do so.

Certain anomalies that “have the potential to cause serious patient harm or death” have been associated with software versions 5.9.2 and earlier. Specifically, “if during an alarm condition the Pause Audio option is repeated 70 times or more, it will result in the pump becoming nonfunctional, which may lead to the patient being underdosed or delay their therapy.” Also, “if a secondary infusion is started at the exact moment a primary infusion completes, then the pump will switch to primary once the secondary infusion completes and Volume to be Infused (VTBI) reaches 0. Then, the primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty, which may lead to the patient being over infused.”

The Ivenix LVP software “is the application embedded in the Ivenix Infusion System. The LVP software controls the functioning of the LVP and exchanges information with Infusion Management System (IMS) applications. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.”