BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1365377 · Received February 3, 2009

    Report

    Report Number
    3003464075-2009-00046
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 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 BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR RUNNING OUT OF SALINE BEFORE COMPLETION OF RINSEBACK. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS IN RESPONSE TO A POWER FAILURE AND PERFORMING RINSEBACK INCLUDING THE MINIMUM AMOUNT OF SALINE REQUIRED. THE EXACT CAUSE OF THE POWER FAILURE IS NOT KNOWN AT THE TIME OF THIS REPORT. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED AND PROVIDED ADDITIONAL TRAINING. 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. AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT, THE CYCLER LOST POWER. POWER WAS RESTORED, BUT TOO MUCH TIME ELAPSED TRIGGERING A POWER FAILURE RECOVERY CAUTION TO THE OPERATOR TO PERFORM A MANUAL RINSEBACK. PARTIAL RINSEBACK WAS PERFORMED, BUT NOT COMPLETED BECAUSE THE OPERATOR RAN OUT OF SALINE, RESULTING IN AN ESTIMATED BLOOD LOSS OF 80CC. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other