BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX CAPILLARY DIALYZER

    MDR report key: 1001879 · Received February 25, 2008

    Report

    Report Number
    9611369-2008-00156
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 29, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K040255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINTS 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 CAPILLARY DIALYZER KDI GAMBRO DIAYLZATOREN GMBH POLYFLUX 17 L 7-4075-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other