BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 1570286 · Received December 3, 2009

    Report

    Report Number
    1527460-2009-00138
    Event Type
    Malfunction
    Date Received
    December 3, 2009
    Date of Event
    October 30, 2009
    Report Date
    November 6, 2009
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE TESTING AND INVESTIGATION RESULTS WERE RECEIVED AND THE COMPLAINT FOR UNDER DELIVERY WAS CONFIRMED. THE POLES WERE MISALIGNED WITHIN THE MOTOR. (B) (4)

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTS AN UNDER DELIVERY. THE REPORTER INDICATED THAT THE RATE WAS SET AT 55 ML/HR TO BE DELIVERED OVER 12 HOURS, HOWEVER, THE ACTUAL AMOUNT RECEIVED WAS 37 ML/HR.

    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 3 YR