BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANGAROO EPUMP

    MDR report key: 4143094 · Received September 25, 2014

    Report

    Report Number
    4143094
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    November 27, 2013
    Report Date
    September 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    NOTED PUMP ROLLER WHEEL MISSING. UPON EXAM, NO VISIBLE DAMAGE TO CASE, WHEEL PLACEMENT IS BEHIND DOOR. ASSUMPTION THAT WHEEL MUST HAVE FALLEN OFF WHEN FEEDING TUBING REMOVED. ASSUMPTION THAT SMALL SCREW THAT HOLDS WHEEL IN PLACE WAS NOT SUFFICIENTLY TIGHTENED. BIOMED REPLACED PUMP WHEEL AND EVALUATED OTHER PUMPS IN STOCK TO ENSURE APPROPRIATE TENSION TO WHEELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597340 KANGAROO EPUMP PUMP, INFUSION, ENTERAL LZH COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *