BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM SET

    MDR report key: 1572600 · Received January 6, 2010

    Report

    Report Number
    1527460-2009-00152
    Event Type
    Death
    Date Received
    January 6, 2010
    Report Date
    December 7, 2009
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K915735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DIETICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE SET WAS PROBABLY DISCARDED. PER ABBOTT DEVICE PROCEDURES, REASONABLE EFFORTS ARE MADE TO OBTAIN THE DEVICE AND ADD'L INFO THROUGH WRITTEN AND/OR VERBAL FOLLOW-UP.

    Description of Event or Problem · 1

    IN 2009, A PT'S ENTERAL FEEDING WAS HOOKED UP TO A DUVALL DRAIN (IN THE ABDOMEN). IT WAS MISTAKEN FOR A MOSS TUBE. THE PT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM SET KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ABBOTT NUTRITION 50608

    Patients

    Seq Age Sex Outcome Treatment
    1 Death