BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION DEVICE

    MDR report key: 3389613 · Received September 30, 2013

    Report

    Report Number
    MW5032129
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Date of Event
    September 20, 2013
    Report Date
    September 27, 2013
    Manufacturer
    SMITHS MEDICAL MD IN
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CADD PUMP MALFUNCTIONED. EPIDURAL ROPIVOCAINE WAS SHOWING TO BE INFUSING AND PUMP WAS SHOWING VTBI AS "0". RN NOTED 60 ML STILL IN VIAL SO PUMP WAS REPROGRAMMED FOR 55 ML VTBI. AT 4 HR CHECK THE VERY SAME AMOUNT WAS NOTED TO BE IN VIAL ALTHOUGH PUMP HAD NOT ALARMED AND VTBI WAS AGAIN "0".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491397 INFUSION DEVICE CADD PUMP MEA SMITHS MEDICAL MD IN 659715

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR