BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX R CAPILLIARY DIALYZER

    MDR report key: 2971353 · Received October 11, 2007

    Report

    Report Number
    9611369-2007-00451
    Event Type
    Malfunction
    Date Received
    October 11, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 20, 2007
    Manufacturer
    GAMBRO DIALYSETOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K010667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL BLOOD LEAK CAN OCCUR DUE TO DAMAGE IN THE HOLLOW FIBRES. NO FURTHER INFO IS EXPECTED FOR THIS SPECIFIC EVENT AND THE CASE IS CONSIDERED CLOSED. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINTS BLOOD LEAK DURING TREATMENT. THE BLOOD LOS WAS CA 300 ML. NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX R CAPILLIARY DIALYZER KDI GAMBRO DIALYSETOREN GMBH POLYFLUX 24 R 7-381Z-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR MEDISYSTEMS BLOODLINES| MACHINE FRESNIUS 2008K