BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1052804 · Received May 27, 2008

    Report

    Report Number
    3003464075-2008-00222
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 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 CLOTTING OF THE EXTRACORPORAL BLOOD CIRCUIT. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVAL. THE EXACT CAUSE OF THE VENOUS AIR ALARM CANNOT BE DETERMINED. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF WAS NOTIFIED OF THE EVENT. 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. A VENOUS AIR ALARM OCCURRED AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT. AIR WAS MANUALLY REMOVED BY OPERATOR BUT RINSEBACK COULD NOT BE COMPLETED DUE TO CLOTTING OF THE CIRCUIT DURING THE ELAPSED TIME TROUBLESHOOTING THE ALARM, 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other