BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 323 VOLUMETRIC INFUSION PUMP

    MDR report key: 6614165 · Received June 1, 2017

    Report

    Report Number
    MW5070177
    Event Type
    Malfunction
    Date Received
    June 1, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 1, 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

    RN REPORTS INFUSION IS FINISHING UP EARLY PUMP IS PROGRAMMING CORRECTLY. BODYGUARD SERIAL NUMBER (B)(4) EXP DATE 09/26/2017. PT HAS NO SIDE EFFECTS FROM PUMP MALFUNCTION. PT'S MOTHER KNOWS NOT TO THROW THE PUMP AWAY, BUT TO RETURN THE PUMP. RETURN BOX SENT. PT'S MOTHER DID NOT AGREE TO MFR CONTACTING HER RE-PUMP MALFUNCTION. REASON FOR USE: E76.1 MUCOPOLYSACCHARIDOSIS, TY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385993 BODYGUARD 323 VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN CAESAREA MEDICAL ELECTRONICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR