BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1030079 · Received April 16, 2008

    Report

    Report Number
    3003464075-2008-00171
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REQUIRED A BLOOD TRANSFUSION AS A RESULT OF THE REPORTED BLOOD LOSS EVENTS WHICH IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS DIRECTED IN THE USER'S GUIDE WHEN A LEAK IS OBSERVED. THE DISPOSABLE CARTRIDGES WERE NOT RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE FLUID LEAKS COULD NOT BE DETERMINED. 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 TREATMENT IF LEAK CANNOT BE RESOLVED." A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT INFO WAS REQUESTED BY NXSTAGE, BUT NOT PROVIDED BY THE REPORTING NURSE. FOUR CARTRIDGES WERE REPORTED AS HAVING CLEAR FLUID LEAKS OBSERVED DURING AN EXTENDED CVVH DIALYSIS TREATMENT. IN EACH INSTANCE, THE OPERATOR ENDED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC EACH. DUE TO THE BLOOD LOSS, THE PT REQUIRED A TRANSFUSION OF TWO UNITS OF BLOOD. NO OTHER 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-501 8017801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other