BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-1283-2024 · Reported March 20, 2024

    Enforcement

    Recall Number
    Z-1283-2024
    Event ID
    93968
    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
    May 10, 2023
    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 corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

    Code Info

    UDI-DI 00811505030122 Software versions 5.2.1/5.2.2

    Distribution

    US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

    Quantity

    6 US