BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1080439 · Received July 21, 2008

    Report

    Report Number
    3003464075-2008-00320
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 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 USER ERROR AS THE OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT DURING TREATMENT. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR PERFORMING AIR REMOVAL. THE EXACT CAUSE OF THE SUBSEQUENT ARTERIAL AIR ALARM IS NOT KNOWN. CLOTTING OF THE CIRCUIT IS ATTRIBUTED TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARMS AND THAT THE TREATMENT IS PERFORMED WITHOUT ANTICOAGULATION. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS EVENTS 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 OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT WHILE ADMINISTERING A FLUID BOLUS WHICH TRIGGERED ON ARTERIAL AIR ALARM. ARTERIAL AIR ALARMS OCCURRED SEVERAL DAYS LATER DURING TREATMENT, ALTHOUGH THE EXACT CAUSE IS UNKNOWN. THE CIRCUIT CLOTTED DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARMS, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH TREATMENT. 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 24 YR Other