BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1251758 · Received December 3, 2008

    Report

    Report Number
    3003464075-2008-00626
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 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 PT'S VASCULAR ACCESS NEEDLE DISLODGING DURING TREATMENT AND SUBSEQUENT AIR IN THE PT'S LINE. FACILITY STAFF ATTRIBUTED THE ACCESS NEEDLE DISLODGING TO USER TECHNIQUE. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L 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 OPERATOR REPORTED THAT THE PT'S ACCESS NEEDLE DISLODGED DURING A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT PERFORMED DUE TO THE AMOUNT OF TIME ELAPSED AND THE PRESENCE OF AIR IN THE LINE, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. 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 8087706

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other