BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLUX H CAPILLARY DIALYZER

    MDR report key: 2230387 · Received August 3, 2011

    Report

    Report Number
    9611369-2011-00004
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 15, 2011
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GAMBRO POLYFLUX 170 H 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 COMPLAINT HISTORY FILE CHECK, AS THE LOT NUMBER INVOLVED IN THE INCIDENT IS UNKNOWN. GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    ACCORDING TO PRELIMINARY INFORMATION, A PATIENT WAS HOSPITALIZED FOLLOWING COMPLETION OF HER DIALYSIS TREATMENT FOR FEVER OR DIARRHEA AND SUBSEQUENTLY DIAGNOSED WITH HEMOLYSIS. THE CAUSE OF THE HEMOLYSIS IS UNKNOWN. NO FURTHER MEDICAL OR CLINICAL DATA IS AVAILABLE AT THIS TIME. THE CLINICAL INVESTIGATION IS PRESENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX H CAPILLARY DIALYZER KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 170 H UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization