BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0002-2023 · Initiated September 8, 2022

    Recall

    Recall Number
    Z-0002-2023
    Event Number
    90845
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    PHC
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 8, 2022
    Posted
    October 6, 2022
    Terminated
    September 10, 2024
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    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.

    Action

    On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: [email protected]; 1-978-775-8100

    Distribution

    Domestic distribution to NJ and WI.

    Quantity

    4 instances