BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1112142 · Received August 6, 2008

    Report

    Report Number
    3003464075-2008-00358
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 9, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO USER ERROR AS THE OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT WHILE CONNECTING A NEW SALINE BAG. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR ALARM RESOLUTION AND AIR REMOVAL PROCEDURES. 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, THE OPERATOR RAN OUT OF SALINE WHILE IN RINSEBACK MODE. AIR WAS INTRODUCED INTO THE CIRCUIT WHILE ATTEMPTING TO CONNECT A NEW SALINE BAG WHICH CAUSED AN ARTERIAL AIR ALARM. DUE TO THE AMOUNT OF VISIBLE AIR IN THE CIRCUIT, THE OPERATOR CHOSE NOT TO COMPLETE RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 40 CC. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other