BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-1282-2024 · Reported March 20, 2024

    Enforcement

    Recall Number
    Z-1282-2024
    Event ID
    93958
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    March 20, 2024
    Initiation Date
    September 16, 2022
    Classification Date
    March 11, 2024
    Address
    50 High St Ste 50, N/A, North Andover, MA, 01845-2620, United States

    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.

    Code Info

    UDI-DI 00811505030122 Software versions 5.0.1 and earlier.

    Distribution

    US Nationwide distribution in the states of WI and NJ.

    Quantity

    3