BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1030081 · Received April 16, 2008

    Report

    Report Number
    3003464075-2008-00174
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 22, 2008
    Report Date
    March 22, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE CIRCUIT PREVENTING RINSEBACK OF THE PT'S BLOOD. FACILITY STAFF ATTRIBUTED THE ARTERIAL AIR AND PRESSURE ALARMS TO ISSUES WITH THE PT'S ACCESS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO 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. AN ARTERIAL AIR AND PRESSURE ALARM OCCURRED WHILE ATTEMPTING TO RAISE THE BLOOD FLOW RATE DURING A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT PERFORMED DUE TO CLOTTING, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. NO 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 7117714

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other