BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX R CAPILLARY DIALYZER

    MDR report key: 1051425 · Received May 20, 2008

    Report

    Report Number
    9611369-2008-00353
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 22, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K994390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED AT THE MOMENT. AS SOON AS WE HAVE THE SAMPLE ON HAND WE WILL START THE INVESTIGATION. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.

    Description of Event or Problem · 1

    IT WAS FOUND MEMBRANE BROKEN DURING FIRST USE. BLOOD FLOW RATE, 117 ML/MIN, TMP, 120MHG. 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 MSF GAMBRO DIALYSATOREN GMBH POLYFLUX 17 R 7-3553-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other