BEUDAMED
    FDA Enforcement Class I Terminated

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

    Recall: Z-0002-2023 · Reported October 12, 2022

    Enforcement

    Recall Number
    Z-0002-2023
    Event ID
    90845
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 12, 2022
    Initiation Date
    September 8, 2022
    Classification Date
    October 6, 2022
    Termination Date
    September 10, 2024
    Address
    50 High St Ste 50, N/A, North Andover, MA, 01845-2620, United States

    Description

    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

    Reason

    The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

    Code Info

    UDI-DI: 00811505030122 version 5.2.0

    Distribution

    Domestic distribution to NJ and WI.

    Quantity

    4 instances