BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYFLUX R CAPILLARY DIALYZER

    MDR report key: 1040703 · Received September 4, 2008

    Report

    Report Number
    2087532-2008-00045
    Event Type
    Other
    Date Received
    September 4, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    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 POLYFLUX R CAPILLARY DIALYZER KDI KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 24 R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other