BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD INFUSION PUMP 323

    MDR report key: 8253760 · Received January 15, 2019

    Report

    Report Number
    MW5083174
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    January 13, 2019
    Report Date
    January 14, 2019
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    BODYGUARD 323 PUMP KEPT ALARMING THAT THERE WAS AN "UP OCCLUSION" SHORTLY AFTER THE HYQVIA IGG INFUSION STARTED (40 MINUTES IN) WHEN THERE WAS NO OCCLUSION (ALL LINES CHANGED) AND THE PUMP WOULD NOT FUNCTION IN ORDER TO CONTINUE THE INFUSION. THIS RESULTED IN NECESSARY MEDICATION NOT BEING DELIVERED AND OVER (B)(6) OF IMMUNE GLOBULIN WASTED GIVEN THE MEDICATION HAS TO BE INJECTED WITHIN A CERTAIN TIME PERIOD AFTER INJECTION OF THE HY FIRST. I ALSO SUFFERED A REACTION DUE TO A MEDICATION THAT IS REQUIRED TO BE INJECTED FIRST(THE HY) AND THEN THE SECOND MEDICATION THE IMMUNE GLOBULIN - NOT BEING INJECTED DUE TO THE PUMP ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44429 BODYGUARD INFUSION PUMP 323 PUMP, INFUSION FRN CME AMERICA LLC 323

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other