BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1063183 · Received June 20, 2008

    Report

    Report Number
    3003464075-2008-00268
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 24, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO USER ERROR AS THE OPERATOR DID NOT PERFORM RINSEBACK IN A TIMELY MANNER. THE CIRCUIT CLOTTED DURING THE TIME THE PATIENT CALLED FACILITY STAFF REGARDING BLOOD PRESSURE ISSUES. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. 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. THE PATIENT WAS EXPERIENCING BLOOD PRESSURE ISSUES DURING A ROUTINE HEMODIALYSIS TREATMENT. DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ISSUE, THE CIRCUIT CLOTTED PREVENTING RINSEBACK OF THE PATIENT'S BLOOD. AN ESTIMATED 190CC BLOOD LOSS OCCURRED. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE BLOOD PRESSURE ISSUES OR THE BLOOD LOSS EVENT.

    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 8027711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other