BEUDAMED
    FDA Adverse Event Other Summary report: N

    NX STAGE SYSTEM ONE

    MDR report key: 596566 · Received April 28, 2005

    Report

    Report Number
    3003464075-2005-00012
    Event Type
    Other
    Date Received
    April 28, 2005
    Date of Event
    April 1, 2005
    Report Date
    April 1, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    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 A ROUTINE HEMODIALYSIS TREATMENT, A VENOUS PRESSURE HIGH ALARM OCCURRED. IT WAS DETERMINED THAT THE EXTRACORPOREAL BLODD CIRCUIT WAS CLOTTED PRECLUDING MANUAL RINSEBACK OF THE PT'S BLOOD. THE CIRCUIT WAS DISCARDED RESULTING IN A BLOOD LOSS OF APPROX 225 CC. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NX STAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-156 FG-050304-01

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other