BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1002521 · Received February 26, 2008

    Report

    Report Number
    3003464075-2008-00082
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO RINSEBACK NOT BEING PERFORMED DUE TO AIR IN THE CIRCUIT. FACILITY STAFF ATTRIBUTED THE ALARM AND SOURCE OF AIR TO BE DUE TO PROBLEMS WITH THE PT'S CATHETER. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. ARTERIAL AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. AIR WAS OBSERVED COMING FROM THE PT'S CATHETER. EFFORTS TO REMOVE THE AIR WERE NOT SUCCESSFUL. RINSEBACK WAS NOT PERFORMED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 210CC. 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 7117711

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other