BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX S CAPILLARY DIALYZER

    MDR report key: 1040930 · Received May 9, 2008

    Report

    Report Number
    9611369-2008-00346
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 11, 2008
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K982414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. BLOOD FLOW RATE: 110 ML/MIN. TMP: 95 MHG. 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 S CAPILLARY DIALYZER KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 14 S 7-3301-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other