BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1111786 · Received September 15, 2008

    Report

    Report Number
    9611369-2008-00725
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Manufacturer
    *
    Product Code
    KDI
    PMA / PMN Number
    K010667
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. THE SAMPLE HAS NOT YET ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE CAN BE DETERMINED AFTER INVESTIGATION. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. THERE WAS INSIGNIFICANT BLOOD LOSS. NO MEDICAL INTERVENTION WAS NEEDED. NO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * KDI * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *