BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1172349 · Received September 19, 2008

    Report

    Report Number
    3003464075-2008-00442
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. EVAL OF THE RETURNED CYCLER WAS NOT COMPLETED AT THE TIME OF THE REPORT. THE ACTUAL CAUSE OF THE ALARMS IS NOT KNOWN AT THIS TIME. A DIRECT CORRELATION BETWEEN NXSTAGE SYS 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. WASTE LINE PRESSURE HIGH ALARMS AND HIGH BALANCE CHAMBER PRESSURE ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. RESISTANCE WAS NOTED IN THE DRAIN LINE. TREATMENT WAS DISCONTINUED. ONLY PARTIAL RINSEBACK PERFORMED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 90CC. 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 8057702

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other