BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX S CAPILLARY DIALYZER

    MDR report key: 1153153 · Received September 4, 2008

    Report

    Report Number
    9611369-2008-00821
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 20, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K982414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE SHOWS LEAKAGE BETWEEN POTTING AND HOUSING. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. 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 POLYFLUX S CAPILLARY DIALYZER KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 21 S 8-2802-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other