BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1192793 · Received October 8, 2008

    Report

    Report Number
    3003464075-2008-00473
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 12, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE EXTRACORPOREAL CIRCUITS. FACILITY STAFF ATTRIBUTED THE CLOTTING AND ALARMS TO A CLOTTED VASCULAR ACCESS WHICH HAS SINCE BEEN SURGICALLY REVISED. 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. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THESE EVENTS. 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. FACILITY STAFF REPORTED THAT THE PATIENT EXPERIENCED VENOUS PRESSURE HIGH ALARMS AT THE START OF TWO CONSECUTIVE ROUTINE HEMODIALYSIS TREATMENTS. RINSEBACK WAS NOT PERFORMED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH TREATMENT. NO MEDICAL INTERVENTION WAS REQUIRED DUE TO THE BLOOD LOSS EVENTS.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other