BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPANION PUMP

    MDR report key: 1834518 · Received September 10, 2010

    Report

    Report Number
    1527460-2010-00168
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REPORTED, LIST NUMBER 00083, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 00084, 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 WAS 480 ML TO BE DELIVERED OVER 8 HOURS; HOWEVER, THE ACTUAL AMOUNT DELIVERED WAS 240 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 00083

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR