BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 2202252 · Received August 5, 2011

    Report

    Report Number
    1527460-2011-00053
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS CONFIRMED AN UNDER-DELIVERY WITH A STUTTERING MOTOR. THE POLE PIECES OF THE MOTOR WERE FOUND TO BE MISALIGNED. THE FRONT PUMP CASE WAS BROKEN. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTS TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED FEEDING RATE WAS 45 ML PER HR AND THE PUMP DELIVERED 200 ML OVER 12 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1