BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL UMP

    MDR report key: 2211977 · Received August 10, 2011

    Report

    Report Number
    1527460-2011-00057
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DIETICIAN

    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 OVER-DELIVERY. THE PUMP FEEDS DOUBLE THE SET DOSE ON THE PUMP DURING THE FIRST FEEDING OF A NEW BOTTLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR