BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX S CAPILLARY DIALYZER

    MDR report key: 1033473 · Received April 23, 2008

    Report

    Report Number
    9611369-2008-00310
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 26, 2008
    Manufacturer
    GAMBRO DIAYLZATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K982414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MFR NARRATIVE. INTERNAL BLOOD LEAKS CAN OCCUR DUE TO DAMAGE OF THE HOLLOW FIBRES. THERE IS NO SAMPLE AVAIL 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 BLOOD LEAK DURING THE TREATMENT. 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 S CAPILLARY DIALYZER KDI GAMBRO DIAYLZATOREN GMBH POLYFLUX 21 S 6-2801-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other