BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM PUMP

    MDR report key: 2160999 · Received June 17, 2011

    Report

    Report Number
    1527460-2011-00038
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K944669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN OVER-DELIVERY. THE PUMP WAS FOUND TO BE DELIVERING TWICE THE SELECTED VOLUME DURING ROUTINE PREVENTATIVE MAINTENANCE.

    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