BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1283-2024 · Initiated May 10, 2023

    Recall

    Recall Number
    Z-1283-2024
    Event Number
    93968
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Completed
    Root Cause
    Software design
    Initiated
    May 10, 2023
    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 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.

    Action

    Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.

    Distribution

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

    Quantity

    6 US