BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 958733 · Received December 5, 2007

    Report

    Report Number
    9611369-2007-00592
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 14, 2007
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K023615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE TO THE HOLLOW FIBRES.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. IT WAS FOUND MEMBRANE BROKE DURING THE FIRST USE: BLOOD FLOW RATE: 120ML/MLN, TMP: 82MHG. 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 DIAYLZATOREN GMBH POLYFLUX 6 LR 6-8615-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other