BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 10060872 · Received May 7, 2020

    Report

    Report Number
    10060872
    Event Type
    Injury
    Date Received
    May 7, 2020
    Date of Event
    April 21, 2020
    Report Date
    April 22, 2020
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BODYGUARD IV PUMP WAS INFUSING. SUDDENLY BEGAN TO RAPIDLY INFUSE FOR 1.3 SECONDS, STOPPED, ALARMED AND PROMPTED STAFF WITH ERROR MESSAGE TO POWER PUMP OFF AND RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500838 INFUSION PUMP INFUSION PUMP FRN CME AMERICA, LLC BODYGUARD 121

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention