BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1357165 · Received January 13, 2009

    Report

    Report Number
    3003464075-2009-00018
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    December 16, 2008
    Report Date
    December 16, 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

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT COMPLETING RINSEBACK OF THE PATIENT'S BLOOD AS INSTRUCTED IN THE USER'S GUIDE. THE CARTRIDGE WAS NOT RETURNED FOR EVALUATION. THE REPORTED LEAK CANNOT BE CONFIRMED. THE USER'S GUIDE INCLUDES ADEQUATE WARNINGS FOR THE OPERATOR TO PERIODICALLY CHECK THE SYSTEM FOR LEAKS AS THE CYCLER MAY NOT SENSE SLOW LEAKS AND TO TERMINATE THE TREATMENT IF A LEAK CANNOT BE RESOLVED. 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 INFORMATION 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 CLEAR FLUID LEAK WAS OBSERVED DURING A ROUTINE HEMODIALYSIS TREATMENT. PARTIAL RINSEBACK WAS PERFORMED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 40CC. 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 8087707

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other