BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1374828 · Received February 24, 2009

    Report

    Report Number
    3003464075-2009-00096
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    February 3, 2009
    Report Date
    February 3, 2009
    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 AIR ALARM AND BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR RUNNING OUT OF SALINE DURING RINSEBACK. THE CYCLER ALARMED APPROPRIATELY. 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. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. 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. A VENOUS AIR ALARM OCCURRED AT THE END OF RINSEBACK OF A ROUTINE HEMODIALYSIS TREATMENT. THE ALARM WAS TRIGGERED WHEN THE SALINE BAG EMPTIED, AND INTRODUCED AIR INTO THE BLOOD CIRCUIT. THE PT'S BLOOD WAS NOT COMPLETELY RINSED BACK DUE TO RUNNING OUT OF SALINE, RESULTING IN AN ESTIMATED BLOOD LOSS OF 50CC. 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 8107730

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other