BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1030083 · Received April 16, 2008

    Report

    Report Number
    3003464075-2008-00176
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    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 CONFIRMED A DIALYSATE LEAK AT THE BALANCE CHAMBER OF THE CARTRIDGE. THE EXACT CAUSE OF THE LEAK IS UNDER INVESTIGATION. THE CYCLER ALARMED APPROPRIATELY. 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 PT VASCULAR ACCESS AND ALL FLUID LINES, CONNECTIONS AND CLAMPS. SECURE THE BLOOD ACCESS DEVICE TO THE PT. VISUALLY INSPECT THE SYSTEM PERIODICALLY FOR EVIDENCE OF LEAKS. TERMINATE TREATMENTS IF 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 WHICH COULD NOT BE RESOLVED. A CLEAR FLUID LEAK WAS OBSERVED. TREATMENT WAS ENDED WITHOUT COMPLETING RINSEBACK OF THE PT'S BLOOD, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. NO MEDICAL INTERVENTION WAS REPORTED.

    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 75 YR Other