BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODYGUARD MICROSET

    MDR report key: 7752486 · Received August 3, 2018

    Report

    Report Number
    MW5078873
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    July 27, 2018
    Report Date
    August 1, 2018
    Manufacturer
    CME AMERICA LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT CAME TO INFUSION CENTER APPROX 1300 ON (B)(6) 2018 FOR 72 HOURS BAG. PT RECEIVED A DOSE FROM THE 72 HOURS BAG AND THEN WAS SENT HOME. AT APPROX 1600, PT CALLED SAYING THAT THE PUMP WAS LEAKING. PT RETURNED TO THE INFUSION CENTER AND THE BODYGUARD TUBING (LOT #19202, EXP: 08/01/2021) WAS LEAKING AT JUNCTION WHERE THE TUBING LEAVES THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587402 BODYGUARD MICROSET BODYGUARD MICROSET FPA CME AMERICA LLC 19202

    Patients

    Seq Age Sex Outcome Treatment
    1