BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1242385 · Received November 21, 2008

    Report

    Report Number
    3003464075-2008-00605
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 25, 2008
    Report Date
    October 25, 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 PT'S BLOOD AS INSTRUCTED IN THE USER'S GUIDE. THE USER'S GUIDE INCLUDES ADEQUATE INSTRUCTIONS FOR MAKING PT CONNECTIONS AND PERFORMING RINSEBACK. PROD WAS NOT RETURNED FOR EVAL 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 ADD'L 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, A SYSTEM ALARM OCCURRED WHICH COULD NOT BE RESOLVED. A CLEAR FLUID LEAK WAS OBSERVED. THE OPERATOR MADE THE INCORRECT CONNECTIONS TO PERFORM RINSEBACK OF THE PT 'S BLOOD. THIS RESULTED IN AN ESTIMATED 190CC BLOOD LOSS. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 8087701

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other