BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUMP

    MDR report key: 2160983 · Received June 17, 2011

    Report

    Report Number
    1527460-2011-00037
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K944669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS INDICATED THE PROBABLE ROOT CAUSE OF THIS FAILURE IS LIKELY DUE TO A FAILURE OF ELECTROLYTIC CAPACITOR C17 (FOUND LOOSE AT THE BOTTOM OF THE PUMP HOUSING). THE CAPACITOR MOST LIKELY LEAKED A SMALL AMOUNT OF ITS CORROSIVE ELECTROLYTE ONTO THE SURFACE OF THE CIRCUIT BOARD. THIS ELECTROLYTE WAS ABLE TO CORRODE THE TRACES IN CLOSE PROXIMITY TO THE CAPACITOR AND THEN CAUSE A LOW RESISTANCE PATH BETWEEN THE 11V AND GROUND TRACES. THIS LOW RESISTANCE PATH ALLOWED CURRENT TO FLOW BETWEEN 11V AND GROUND, A BYPRODUCT OF WHICH IS HEAT. THE HEAT GENERATED WAS ENOUGH TO SCORCH THE CIRCUIT BOARD AND CAUSE SMOKE. IT IS IMPORTANT TO NOTE THAT THERE WAS NO ACTUAL FIRE CAUSED BY THIS HEAT AS THE BOARD IS CONSTRUCTED FROM A MATERIAL CARRYING A 94V-0 FLAMMABILITY RATING, MEANING THAT IT IS NOT FLAMMABLE. THIS BOARD WAS IN OPERATION FOR GREATER THAN 11 YRS. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED VISIBLE SMOKE COMING OUT OF PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 50598

    Patients

    Seq Age Sex Outcome Treatment
    1