BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPANION SET

    MDR report key: 1910741 · Received November 23, 2010

    Report

    Report Number
    1527460-2010-00196
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REPORTED, LIST NUMBER 00507, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 00507, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2010-00193. THE REPORTER INDICATED THE BABY USING THE PUMP LOST 0.5 KG IN 10 DAYS. THE PUMP IS NOT PUMPING AT THE RIGHT RATE. THE PUMP IS UNDER-DELIVERING. THE REPORTER HAS DONE TWO ACCURACY TESTS ON THE PUMP AT THE PHARMACY. TEST #1 WASHED AND USED THE SAME FEEDING SET THAT THE PARENTS RETURNED AND STATES THAT IT IS DEFINITELY UNDER DELIVERING. THE REPORTER CONFIRMED THE "VOLUME FED" WAS CLEARED BEFORE EACH FEEDING. THE INTENDED DELIVERY WAS APPROX 56 ML (RATE OF 28 ML/HR, OVER 2 HOUR TIME FRAME). THE ACTUAL AMOUNT DELIVERED WAS 30 ML. TEST #2 THE INTENDED DELIVERY WAS 120 ML/HR OVER 75 MINUTES, THE ACTUAL AMOUNT DELIVERED WAS 60 ML. ADD'L INFO RECEIVED 11/05/2010: THE REPORTER INDICATED TESTS #1 AND #2 WERE CONDUCTED USING THE INITIAL FEEDING SET (WASHED AND USED THE SAME FEEDING SET THAT THE PARENTS RETURNED). THE CAREGIVER REPORTED THE BABY IS DOING WELL. REPORTED THAT SHE WAS CHANGING THE FEEDING SETS EVERY 3 DAYS IN THE PAST AND IS NOW CHANGING THEM EVERY 24 HOURS. THE REPORTER INDICATED THE SETS ARE CHANGED EVERY 72 HOURS. THE SET LABEL STATES THAT IN ORDER TO AVOID PRODUCT CONTAMINATION PROBLEMS, THE SET SHOULD BE REPLACED AT LEAST EVERY 24 HOURS, 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 87269LE

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Required Intervention