BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1012553 · Received February 14, 2008

    Report

    Report Number
    9611369-2008-00115
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K010657
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. AS SOON AS THE SAMPLE ARRIVES WE WILL START INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THE MOMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1