BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE

    MDR report key: 6123203 · Received November 22, 2016

    Report

    Report Number
    8030638-2016-00017
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 22, 2016
    Manufacturer
    GAMBRO RENAL PRODUCTS S.A. DE C.V.
    Product Code
    FJK
    PMA / PMN Number
    K070414
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A DIALYSIS TREATMENT ON A PHOENIX MACHINE WITH A CARTRIDGE BLOOD LINE AND REVACLEAR 300 DIALYZER. APPROXIMATELY 90 MINUTES INTO THE TREATMENT THE PATIENT DEVELOPED NAUSEA, HYPERTENSION AND SHORTNESS OF BREATH. THE SPENT DIALYSATE TESTED POSITIVE FOR PRESENCE OF BLOOD AND THE BLOOD SAMPLE DRAWN WAS HEMOLYZED. TREATMENT WAS ENDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL. AN EKG WAS NORMAL AND THE HEMOGLOBIN AND HEMATOCRIT LEVELS WERE STABLE. THE ANTIBIOTIC WAS DISCONTINUED AS HEMOLYSIS IS A KNOWN SIDE EFFECT. THE PATIENT WAS DISCHARGED THE NEXT MORNING AFTER LAB VALUES STABILIZED AND THE SYMPTOMS RESOLVED. THE PHOENIX (B)(4) WAS INSPECTED AND FOUND TO BE OPERATING WITHIN MANUFACTURER SPECIFICATIONS. THE DISPOSABLES WERE DISCARDED AND NOT AVAILABLE FOR ANALYSIS. THE CAUSE OF THE HEMOLYSIS IS UNKNOWN ALTHOUGH IT IS SUSPECTED TO BE CAUSED BY THE ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772880 CARTRIDGE SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PHOENIX MACHINE, REVACLEAR 300 DIALYZER