BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION SET

    MDR report key: 1833654 · Received September 10, 2010

    Report

    Report Number
    1527460-2010-00166
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 PUMP IS NOT DELIVERING THE INTENDED AMOUNT. THE BABY HAS BEEN LOSING AND GAINING WEIGHT ON AND OFF. HE IS FAILING TO THRIVE. HE SHOULD BE RECEIVING 792 ML IN 24 HOURS AND IS ONLY GETTING 350 ML IN THAT TIME FRAME. AMOUNT HUNG WAS 200-300 MLS AT A TIME WITH A FEEDING SET RATE OF 33 ML/HR. METHOD OF MEASUREMENT WAS BY VISUAL ASSESSMENT. THE REPORTER INDICATED THE PT WAS ADMITTED TO THE HOSPITAL AT LEAST 3 TIMES IN A PERIOD OF 2 MONTHS. PT WAS AT 5.2 KG AND WAS ADMITTED TO HOSPITAL SINCE WEIGHT DROPPED TO 4.8 KG IN ONLY 4 DAYS. THE LOWEST WEIGHT WAS 4.7 KG. REPORTER STATES THE PT IS NOW ON THE SAME FORMULA BUT A DIFFERENT PUMP AND CONTAINER AND THAT THE PT IS NOT LOSING WEIGHT ANYMORE. REPORTER HAS REQUESTED THAT THEY NOT BE CONTACTED FOR ADDITIONAL INFO. THE REPORTER INDICATED THE SETS ARE CHANGED EVERY 2 DAYS. THE SET LABEL STATES THAT IN ORDER TO AVOID PRODUCT CONTAMINATION PROBLEMS, THE SET SHOULD BE REPLACED AT LEAST EVERY 24 HRS, OR AS NEEDED. THE COMPLAINANT WAS INSTRUCTED ON THE PROPER FREQUENCY FOR CHANGING THE FEEDING SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPANION SET KNT, TUBES GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 00507 84239LE

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention