BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYFLUX R CAPILLARY DIALYZER

    MDR report key: 1020758 · Received March 3, 2008

    Report

    Report Number
    2087532-2008-00022
    Event Type
    Other
    Date Received
    March 3, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    GAMBRO DIAYLZSATOREN GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINTS BLOOD LEAK DURING THE TREATMENT. THE BLOOD LOSS INSIGNIFICANT. 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 DIAYLZSATOREN GMBH POLYFLUX 24 R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other