BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYFLUX R CAPILLARY DIALYZER

    MDR report key: 1161109 · Received July 11, 2008

    Report

    Report Number
    2087532-2008-00068
    Event Type
    Other
    Date Received
    July 11, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 16, 2008
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINTS BLOOD LEAK DURING THE TREATMENT. THE BLOOD LOSS WAS INSIGNIFICANT. NO PT HARM AND NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX R CAPILLARY DIALYZER KDI KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 24 R 8-3906-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other