BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1242404 · Received November 21, 2008

    Report

    Report Number
    3003464075-2008-00600
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 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. PRODUCT WAS NOT RETURNED AT THE TIME OF THIS REPORT FOR EVALUATION AS REQUESTED. 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, THE CYCLER POWERED OFF. A CLEAR FLUID LEAK WAS OBSERVED. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, DUE TO POSSIBLE CLOTTING 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 8087701

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other