BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYFLUX H CAPILLARY DIALYZER

    MDR report key: 3113342 · Received April 11, 2007

    Report

    Report Number
    2087532-2007-00075
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Date of Event
    March 13, 2007
    Report Date
    March 14, 2007
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS BLOOD LEAK AFTER FIVE MINUTES INTO TREATMENT. THE BLOOD LOSS FOR THE PT ESTIMATED ABOUT 245ML FROM THE BLOOD IN THE EXTRACORPOREAL CIRCUIT. BY CLINICAL POLICY IT WAS NOT RETURNED. NO MEDICAL INTERVENTION. MFR REF # 9611369-2007-00146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX H CAPILLARY DIALYZER KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 170 H 6-4726-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other MEDISYSTEM 8MM BLOODLINE