BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1242388 · Received November 21, 2008

    Report

    Report Number
    3003464075-2008-00602
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 25, 2008
    Report Date
    October 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. NO PROBLEM WAS FOUND WITH EITHER OF THE CARTRIDGES RETURNED FOR EVALUATION. FACILITY STAFF ATTRIBUTED THE REPORTED ALARMS TO OPERATOR ERROR AND ARE PROVIDING ADDITIONAL TRAINING. A DIRECT CORRELATION BETWEEN THE NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. DURING TWO ROUTINE HEMODIALYSIS TREATMENTS ON CONSECUTIVE DAYS, ARTERIAL PRESSURE ALARMS OCCURRED WHICH COULD NOT BE RESOLVED. LOW VENOUS PRESSURE ALARMS OCCURRED INDICATING LIKELY CLOTTING OF THE EXTRACORPOREAL BLOOD CIRCUIT. RINSEBACK WAS NOT PERFORMED DUE TO THE CLOTTING RESULTING IN AN ESTIMATED 190CC BLOOD LOSS FOR EACH TREATMENT. 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 8087712

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other