BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD 323 INFUSION PUMP

    MDR report key: 7163785 · Received January 3, 2018

    Report

    Report Number
    MW5074396
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 12, 2017
    Report Date
    December 12, 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'S PUMP BODYGUARD 323, SERIAL #(B)(4), EXP DATE: 01/25/2018 WILL NOT WORK. PT'S PUMP QUIT IN THE MIDDLE OF THE LAST INFUSION, PT HAD TO HAVE A GRAVITY INFUSION. PUMP WILL NOT CHARGE OR TURN ON. NO SIDE EFFECTS TO PT FOR PUMP MALFUNCTION. PT RECEIVED INFUSION. PT'S MOTHER KNOWS TO RETURN PUMP. PT'S MOTHER DID NOT INDICATE IF THE MFR COULD CONTACT HER "RE PUMP UNCTION." DOSE OR AMOUNT: 24 MG, FREQUENCY: EVERY WEEK, ROUTE: IV. DATES OF USE: (B)(6) 2010 TO ONGOING. DIAGNOSIS OR REASON FOR USE: E76.1 MUCOPOLYSACCHARIDOSIS, TY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6324 BODYGUARD 323 INFUSION PUMP BODYGUARD 323 FRN CAESAREA MEDICAL ELECTRONICS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR