BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1040588 · Received May 9, 2008

    Report

    Report Number
    3003464075-2008-00197
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. FACILITY STAFF ATTRIBUTED THE ALARMS AND BLOOD LOSS TO CLOTTING OF THE PATIENT'S ACCESS, WHICH HAS SINCE BEEN REPAIRED. 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 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. ARTERIAL AIR ALARMS OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED. PRESSURE ALARMS OCCURRED WHILE ATTEMPTING TO RESOLVE THE AIR ALARM. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S ROUTINE EPOGEN DOSE WAS INCREASED. NO OTHER 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 7127713

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other