BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1222115 · Received November 5, 2008

    Report

    Report Number
    3003464075-2008-00554
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 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 PERFORMING RINSEBACK OF THE PT'S BLOOD AS INSTRUCTED IN THE USER'S GUIDE. EVALUATION OF THE RETURNED CARTRIDGE IDENTIFIED A DIALYSATE LEAK IN THE DISPOSABLE FLUID PATH. THE OCCURRENCE OF SIMILAR LEAKS HAS BEEN INVESTIGATED AND AN EXACT ASSIGNABLE CAUSE CANNOT BE DETERMINED. APPROPRIATE ACTION HAS BEEN TAKEN TO REDUCE THE OCCURRENCE OF LEAKS. 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 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 SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. A CLEAR FLUID LEAK WAS OBSERVED. RINSEBACK WAS NOT PERFORMED PER FACILITY PROTOCOL, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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 8067708

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other