BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1040591 · Received May 9, 2008

    Report

    Report Number
    3003464075-2008-00200
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 12, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY STAFF ATTRIBUTED THE CLOTTING AND REPORTED BLOOD LOSS TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARMS. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE ALARMS CANNOT BE DETERMINED. THE USER'S GUIDE IDENTIFIES PROBABLE CAUSE OF ALARMS AND PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING ALARMS AND PERFORMING RINSEBACK. 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. A BALANCE CHAMBER PRESSURE AND WASTE BAG PRESSURE ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED. CLOTTING IN THE EXTRACORPOREAL BLOOD CIRCUIT PREVENTED RINSEBACK AND 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 8017718

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other