BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 1153129 · Received September 4, 2008

    Report

    Report Number
    9611369-2008-00797
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    February 8, 2008
    Report Date
    August 14, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K023615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES. THE SAMPLE HAS NOT ARRIVED FOR INVESTIGATION YET. THE ROOT CAUSE CAN BE DETERMINED AFTER INVESTIGATION.

    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 LR CAPILLARY DIALYZER MSF GAMBRO DIALYSATOREN GMBH POLYFLUX 6 LR 7-8104-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other