BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 2080158 · Received April 7, 2011

    Report

    Report Number
    1527460-2011-00027
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE REPORTED, LIST NUMBER 52034, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 52036, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY AMOUNT WAS 76 ML/HR; HOWEVER, THE ACTUAL AMOUNT RECEIVED WAS 43 ML OVER 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52034

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO