BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX LR CAPILLARY DIALYZER

    MDR report key: 1051428 · Received May 20, 2008

    Report

    Report Number
    9611369-2008-00378
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 20, 2008
    Report Date
    April 29, 2008
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    MSF
    PMA / PMN Number
    K023615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS ABOUT BLOOD LEAK DURING TREATMENT. BLOOD FLOW RATE: 116 ML/MIN. TMP: 110MHG. 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 LR CAPILLARY DIALYZER MSF GAMBRO DIALYSATOREN GMBH POLYFLUX 6 LR 6-8607-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other