BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1202796 · Received October 15, 2008

    Report

    Report Number
    3003464075-2008-00493
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK DUE TO CLOTTING OF THE PATIENT'S CIRCUIT. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE WARNS THAT THE RISK OF BLOOD CLOTTING IN THE CARTRIDGE AND FILTER INCREASES DURING LONG TREATMENTS, WHEN BLOOD FLOW STOPS, AND WHEN NO ANTICOAGULATION IS USED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED AND WILL REVIEW THE EVENT WITH THE OPERATOR. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. A VENOUS PRESSURE HIGH ALARM OCCURRED TOWARD THE END OF A ROUTINE HEMODIALYSIS TREATMENT. CLOTTING WAS OBSERVED SO TREATMENT WAS ENDED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S STANDARD EPOGEN DOSE WAS INCREASED DUE TO LOW HEMOGLOBIN PRIOR TO THE EVENT. POST EVENT, THE PATIENT IS RECEIVING IV IRON. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 8067709

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other