BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN KANGAROO EPUMP

    MDR report key: 9213866 · Received October 21, 2019

    Report

    Report Number
    3007409280-2019-00050
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    September 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    COVIDIEN
    Product Code
    LZR
    PMA / PMN Number
    K143263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. INCOMING VISUAL INSPECTION FOUND NO ANOMALIES. TECHNICAL VISUAL INSPECTION FOUND NO ANOMALIES. DEVICE EVALUATION FOUND A MECHANICAL FAILURE IN THE MOTOR. THE EPUMP MOTOR WAS REPLACED WITH A NEW OEM PART. THE SOFTWARE WAS SET TO 4.009. THE DEVICE WAS CALIBRATED. THE CASE WAS CHECKED FOR DAMAGE. THE CIRCUIT BOARDS WERE INSPECTED. THE ALARM, BATTERY, DISPLAY, KEYPAD, PATIENT SIDE OCCLUSION, RATE ACCURACY, SELF TEST/POWER, UPSTREAM OCCLUSION AND FINAL VISUAL INSPECTION WERE ALL TESTED AND PASSED. THE ROOT CAUSE FOR THE CONFIRMED REPORTED EVENT WAS DETERMINED TO BE THE FAILED MOTOR DUE TO AGING. THIS TYPE OF EVENT WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION AND INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    REPORTEDLY, POST REPAIR, THE DEVICE TURNS ON, DOES THE COUNTDOWN TO SHUT DOWN AND SHUTS OFF. ALSO, WHEN IT IS PLUGGED IN THE BATTERY INDICATOR DOES NOT COME ON. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008596 COVIDIEN KANGAROO EPUMP PUMP, INFUSION, ENTERAL LZR COVIDIEN FICV2100

    Patients

    Seq Age Sex Outcome Treatment
    1