BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1311901 · Received February 10, 2009

    Report

    Report Number
    3003464075-2009-00062
    Event Type
    Injury
    Date Received
    February 10, 2009
    Date of Event
    January 14, 2009
    Report Date
    January 14, 2009
    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 DUE TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. FACILITY STAFF ATTRIBUTED THE ALARMS TO PROBLEMS WITH THE PATIENT'S CATHETER. THE CYCLER ALARMED APPROPRIATELY. THE PATIENT HAS SINCE BEEN TREATED WITH TPA FOR THE CATHETER ISSUES. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. 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. VENOUS PRESSURE HIGH ALARMS AND VENOUS AIR ALARMS OCCURRED TOWARD THE END OF A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT PREFORMED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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 8117704

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other