BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GFS PLUS CAPILLARY DIALYZER

    MDR report key: 1051424 · Received May 20, 2008

    Report

    Report Number
    9611369-2008-00351
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 21, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    FJI
    PMA / PMN Number
    K892523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. NO SAMPLE IS AVAILABLE FOR INVESTIGATION. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. GAMBRO DOES NOT REGARD THE SUBMISSION OF THIS REPORT AS AN ADMISSION OF LIABILITY.

    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 GFS PLUS CAPILLARY DIALYZER FJI GAMBRO DIALYSATOREN GMBH GFS PLUS 12 7-2119-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other