BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATROL SET

    MDR report key: 2181298 · Received July 21, 2011

    Report

    Report Number
    1527460-2011-00048
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K943240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETAINED SAMPLES WERE TESTED, AND NO LEAKS WERE PRESENT. EACH SET PRIMED, FUNCTIONED, AND DELIVERED CORRECTLY WHEN TESTED. IF ADDITIONAL INFORMATION/CLARIFICATION IS OBTAINED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2011-00047 AND 1527460-2011-00049. THE REPORTER STATED SHE HAS A PATROL PUMP THAT USES ABBOTT BAGS, AND FOR A WEEK SHE HAS BEEN USING 2-4 BAGS A NIGHT DUE TO THE BAGS LEAKING IN THE TUBING THAT GOES AROUND THE WHEEL (ROTOR). SHE HAS TRIED THREE DIFFERENT BOXES WITH THREE DIFFERENT LOT NUMBERS. THIS SYSTEM FEEDS HER DAUGHTER ABBOTT NUTRITIONAL FEED AT NIGHT TO HELP HER GET HER CALORIES SO IT IS AN INCONVENIENCE WHEN SHE HAS TO BE HOOKED UP ALL DAY DUE TO NOT GETTING ALL HER FEED AT NIGHT DUE TO THE BAGS LEAKING. THE LEAKING STARTS APPROXIMATELY 1-3 HOURS INTO THE FEEDING. THE PATIENT RECEIVES THREE CANS OF FEED AT A RATE OF 45ML/HR TO BE DELIVERED OVER A TIME FRAME OF 10.5 HOURS. IT IS UNKNOWN HOW MUCH FEEDING THE PATIENT ACTUALLY RECEIVED. THE REPORTER STATED THE PATIENT'S WEIGHT WAS (B)(6) PRIOR TO THE WEIGHT LOSS, AND HER DAUGHTER HAS ALREADY LOST (B)(6) IN A WEEK'S TIME DUE TO THIS PROBLEM. THE REPORTER INDICATED THE WEIGHT LOSS WAS CONFIRMED BY TWO DOCTOR'S OFFICE VISITS. THERE WAS NO ILLNESS OR MEDICAL INTERVENTION AS A RESULT AS THE PATIENT CONTINUED TO RECEIVE FEEDING VIA PUMP AND SYRINGE AND DID NOT LOSE ANY ADDITIONAL WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL SET KNT, TUBES GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 52048 01293RY

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other DEPAKOTE 125MG - 3 X DAY| CLARITIN UNKNOWN MG - 2 X DAY| ZOPENEX UNKNOWN MG DURING ALLERGY SEASON- 2 X DAY| DIASTATE 5MG - PRN