BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYFLUX R CAPILLARY DIALYZER

    MDR report key: 1020760 · Received February 20, 2008

    Report

    Report Number
    2087532-2008-00016
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    January 6, 2008
    Report Date
    January 29, 2008
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINTS BLOOD LEAK DURING THE TREAMENT. THE BLOOD LOSS WAS 303 ML. NO PT HARM AND NO MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX R CAPILLARY DIALYZER KDI KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 24 R 7-3939-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other