BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX S CAPILLARY DIALYZER

    MDR report key: 1002733 · Received February 27, 2008

    Report

    Report Number
    9611369-2008-00162
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 30, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K982414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    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 14 S 7-2811-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other