BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX L CAPILLARY DIALYZER

    MDR report key: 2247598 · Received September 9, 2011

    Report

    Report Number
    9611369-2011-00005
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 15, 2011
    Manufacturer
    GAMBRO DIALYSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO POLYFLUX 17 L DIALYZER WAS USED IN THE DIALYSIS TREATMENT. THE DIALYZER INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE FACILITY. GAMBRO COULD NOT PERFORM A LOT HISTORY RECORD CHECK OR A COMPLAINT HISTORY FILE CHECK, AS THE LOT NUMBER FOR THIS DIALYZER IS NOT KNOWN.

    Description of Event or Problem · 1

    OTHER THAN A BRIEF EPISODE OF NAUSEA THE PT HAD AN UNEVENTFUL DIALYSIS TREATMENT WITH NORMAL ARTERIAL AND VENOUS PRESSURES. THREE MINUTES BEFORE END OF TREATMENT THE BLOOD PUMP STOPPED WITHOUT ANY ALARMS AND TREATMENT COULD NOT BE RESTARTED. THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PT RESULTING IN A BLOOD LOSS OF APPROX 200 - 300 ML. FOLLOWING DISCONNECTION, THE PT DEVELOPED FEVER AND CHILLS. A HEMOGLOBIN LEVEL WAS DRAWN VIA THE ASTRUP METHOD THAT REVEALED HER HEMOGLOBIN LEVEL WAS 6.1 GM D/L. THE PT WAS HOSPITALIZED; THE INITIAL BLOOD DRAWN FROM THE PT WAS REPORTED TO BE HEMOLYZED. THE BLOOD WORK INDICATED THE PT'S HEMOGLOBIN WAS 7.5 GM/D/L. THERE WAS NO BLOOD SMEAR OR HAPTOGLOBIN TEST PERFORMED. THE CLINIC REPORTED THE BLOOD WORK "SHOWED HEMOLYSIS" AND THE SECONDARY BLOOD DRAWN CONFIRMED "HEMOLYSIS." THE DIALYZER WAS DISCARDED AND THE LOT NUMBER WAS UNK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX L CAPILLARY DIALYZER KDI GAMBRO DIALYSATOREN GMBH POLYFLUX 17 L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization