BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAGE SYSTEM ONE

    MDR report key: 1051256 · Received May 22, 2008

    Report

    Report Number
    3003464075-2008-00219
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 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

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE EXTRACORPOREAL CIRCUIT DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARM. THE REPORTED ALARM IS ATTRIBUTED TO DIFFICULTIES WITH THE PT'S FISTULA NEEDLE. 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. 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. THE TRAINING NURSE ENTERED RECIRCULATION MODE DUE TO DIFFICULTIES WITH THE PT'S FISTULA NEEDLE. WHILE ATTEMPTING TO CORRECT THE NEEDLE AN ARTERIAL PRESSURE ALARM OCCURRED. RINSEBACK WAS NOT PERFORMED DUE TO CLOTTING OF THE CIRCUIT, READING IN AN ESTIMATED BLOOD LOSS OF 60CC. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other