BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1081690 · Received July 24, 2008

    Report

    Report Number
    3003464075-2008-00330
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY IN RESPONSE TO THE EMPTY SALINE BAG. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE CIRCUIT DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARM. THE USER'S GUIDE CONTAINS ADEQUATE INSTRUCTIONS FOR RINSEBACK INCLUDING THE VOLUME OF SALINE THAT MUST BE AVAILABLE. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. 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. AN ARTERIAL AIR ALARM OCCURRED DURING RINSEBACK MODE OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR OBSERVED THE SALINE BAGS WERE EMPTY AND CONNECTED NEW SALINE BAGS. THE CIRCUIT CLOTTED DURING THIS TIME PREVENTING RINSEBACK AND RESULTING IN AN ESTIMATED BLOOD LOSS OF 125CC. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other