BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY GUARD PUMP

    MDR report key: 6894052 · Received September 25, 2017

    Report

    Report Number
    MW5072431
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    September 4, 2017
    Report Date
    September 20, 2017
    Manufacturer
    CAESAREA MEDICAL ELECTRONICS LTD
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED BODYGUARD PUMP SERIAL # (B)(4), EXP DATE: 11/04/2017 WAS NOT WORKING, KEPT BEEPING. THE BATTERY WOULD NOT HOLD A CHARGE. THE PUMP NEEDED TO BE PLUGGED BACK IN ORDER TO COMPLETE THE INFUSION. PT COMPLETED THE INFUSION WITHOUT SIDE EFFECTS, NO REACTIONS. THE PT'S RN RETURNED THE PUMP TO THE MFR. THE PT DID NOT SAY THE MFR WAS ABLE TO CONTACT THE PT. DOSE OR AMOUNT: 60 MG, FREQUENCY: EVERY 2 WEEKS, ROUTE: IV. DATES OF USE: FROM (B)(6) 2017 TO ONGOING. DIAGNOSIS OR REASON FOR USE: E75.21 FABRY(-ANDERSON) DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671094 BODY GUARD PUMP PUMP INFUSION FRN CAESAREA MEDICAL ELECTRONICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR