BEUDAMED
    FDA Recall Completed

    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

    Recall: Z-1282-2024 · Initiated September 16, 2022

    Recall

    Recall Number
    Z-1282-2024
    Event Number
    93958
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Completed
    Root Cause
    Software design
    Initiated
    September 16, 2022
    Posted
    March 11, 2024
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

    LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

    Reason

    Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

    Action

    The issue was resolved through an update of the software to Version 5.2.1, which was installed at customer sites in September 2022. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product. There have been two subsequent software upgrades since Version 5.2.1 was released. Consignees are now on v 5.8.0.

    Distribution

    US Nationwide distribution in the states of WI and NJ.

    Quantity

    3