BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASCITES SHUNT, PERC ACCESS KIT, DOUBLE VALVE

    MDR report key: 1195644 · Received October 10, 2008

    Report

    Report Number
    1423507-2008-00079
    Event Type
    Death
    Date Received
    October 10, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 9, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION HAS BEEN FORWARDED TO THE MANUFACTURING FACILITY FOR INVESTIGATION, AND THE RESULTS OF THE INVESTIGATION ARE PENDING. FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    SHUNT BEING USED IN A PATIENT. ACCORDING TO THE DOCTOR, PRIOR TO THE INCIDENT, THE SHUNT WAS STILL FLOWING, BUT WAS PUMPING LESS VOLUME THAN USUAL. THE FLUID IS CHYLOUS FROM A LYMPHATIC DISORDER, AND LIKELY CREATING A SLOWLY BUILDING OCCLUSION. PHYSICIAN WOULD LIKE TO DO A STUDY USING THE HUBER NEEDLE TO FIND THE OCCLUSION. PATIENT HAS PASSED AWAY, FOLLOWING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCITES SHUNT, PERC ACCESS KIT, DOUBLE VALVE ASCITES SHUNT, PERC ACCESS KIT, DOUBLE VALVE KPM CARDINAL HEALTH 42-2050 10443

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death