BEUDAMED
    FDA Recall Open, Classified

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    Recall: Z-2635-2023 · Initiated April 22, 2022

    Recall

    Recall Number
    Z-2635-2023
    Event Number
    92973
    Firm
    Fresenius Kabi USA, LLC
    FEI Number
    3014732157
    Product Code
    FRN
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 22, 2022
    Posted
    September 25, 2023
    Address
    50 High St, Ste 50, North Andover, MA, 01845-2620

    Description

    Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

    Reason

    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

    Action

    Ivenix initiated contact on 4/22/22/ via phone communicating the contents of the customer letter which was then emailed to each customer. Letter states reason for recall, health risk and action to take: Please note, the specified start-up flow accuracy of up to +8% is maintained throughout the extended start-up time; and the steady-state flow accuracy of +l-SYo of the LVP is not affected with this condition. There is no corrective action you need to take at this time. We believe that this condition is low risk in that the affected flow rate range is limited, the start'up flow rate accuracy is unaffected and still within specifications, and the clinical practice of monitoring patients while administering high alert drugs mitigates the risk. Ivenix is working on a software update to correct this condition. It will be available in approximately 60 days. We will inform you when that update is ready to install. If you have additional questions, please contact your Ivenix representative or support below. Customer support - email Customer support - phone [email protected] I-978-775-8TAA

    Distribution

    US Nationwide distribution in the states of NJ, WI.

    Quantity

    1344 pumps