BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 906306 · Received September 4, 2007

    Report

    Report Number
    9611369-2007-00323
    Event Type
    Malfunction
    Date Received
    September 4, 2007
    Date of Event
    July 13, 2007
    Manufacturer
    GAMBRO DIALYZATOREN 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. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT WAS FOUND MEMBRANE BROKEN DURING THE FIRST USE. BLOOD FLOW RATE: 2500ML/MLN; TMP: 500MMHG; NO PATIENT HARM AND THE BLOOD LOSS WAS ABOUT 6-10ML. NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX LR CAPILLARY DIALYZER MSF GAMBRO DIALYZATOREN GMBH POLYFLUX 6 LR 6-8613-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other FRESENIUS