BEUDAMED
    FDA Enforcement Class I Ongoing

    8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

    Recall: Z-0123-2024 · Reported November 1, 2023

    Enforcement

    Recall Number
    Z-0123-2024
    Event ID
    92978
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 1, 2023
    Initiation Date
    September 21, 2023
    Classification Date
    October 25, 2023
    Address
    901 Marcon Blvd, N/A, Allentown, PA, 18109-9512, United States

    Description

    8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System

    Reason

    Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

    Code Info

    UDI-DI: 04046964660887 Serial Numbers: 868497 -892669 ***Updated 8/7/24*** SNs added: 430056, 430119, 430155, 430243, 551518, 685947, 703196, 705968, 726936, 737729, 753364, 774163, 790843, 814074

    Distribution

    Domestic distribution nationwide. Foreign distribution to Canada.

    Quantity

    9771