BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1112758 · Received August 11, 2008

    Report

    Report Number
    3003464075-2008-00368
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 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 PATIENT'S BLOOD IN A TIMELY MANNER AS INSTRUCTED IN THE USER'S GUIDE. EVALUATION OF THE RETURNED CARTRIDGE CONFIRMED A DIALYSATE LEAK AT THE BALANCE CHAMBER OF THE CARTRIDGE. THE EXACT CAUSE OF THE LEAK IS UNDER INVESTIGATION. THE USER'S GUIDE INCLUDES THE FOLLOWING WARNING, "THE NXSTAGE CYCLER MAY NOT SENSE SLOW FLUID OR BLOOD LEAKS RESULTING FROM LOOSE CONNECTIONS, FAULTY COMPONENTS, VENOUS ACCESS DISCONNECTION OR OTHER POTENTIAL CAUSES. LEAKING FLUIDS COULD LEAD TO BLOOD LOSS, INJURY, OR DEATH. LEAKING FLUIDS COULD ALSO CAUSE A PERSON TO SLIP OR FALL. ALWAYS TIGHTEN AND RECHECK PATIENT VASCULAR ACCESS AND ALL FLUID LINES, CONNECTIONS AND CLAMPS. SECURE THE BLOOD ACCESS DEVICE TO THE PATIENT. VISUALLY INSPECT THE SYSTEM PERIODICALLY FOR EVIDENCE OF LEAKS. TERMINATE TREATMENT IF LEAK CAN NOT 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 FLUID LEAK WAS OBSERVED DURING A ROUTINE HEMODIALYSIS TREATMENT. TREATMENT WAS DISCONTINUED. PARTIAL RINSEBACK WAS COMPLETED RESULTING IN AN ESTIMATED BLOOD LOSS OF 95CC. 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 8037713

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other