BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD PUMP 50MG/VL

    MDR report key: 8042380 · Received November 5, 2018

    Report

    Report Number
    MW5081085
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 21, 2018
    Report Date
    October 22, 2018
    Manufacturer
    CME AMERICA LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SPONTANEOUS CALL RECEIVED FROM RN REPORTS PUMP DID NOT INFUSE ALL OF MEDICATION. PUMP READ TOTAL INFUSION 525 ML 120 ML WAS LEFT IN THE INFUSION BAG. INFUSION RATE 250 ML/HR. NO SIDE EFFECTS FROM PUMP MALFUNCTION. PT WAS ABLE TO RECEIVE ALL OF INFUSION. REPLACEMENT PUMP BEING SENT TO PT FOR NEXT INFUSION. WE REPLACED THE DEVICE. DOSE OR AMOUNT: 1750MG/525 ML, FREQUENCY: EVERY 2 WKS, ROUTE: IV. DATES OF USE: FROM "(B)(6) 2014" TO CURRENT. DIAGNOSIS OR REASON FOR USE: E74.02 POMPE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876609 BODYGUARD PUMP 50MG/VL PUMP, INFUSION FRN CME AMERICA LLC 50638

    Patients

    Seq Age Sex Outcome Treatment
    0