BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1080432 · Received July 21, 2008

    Report

    Report Number
    3003464075-2008-00325
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    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

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS INSTRUCTED IN THE USER'S GUIDE. CLEAR FLUID WAS OBSERVED, INDICATING THAT THE CYCLER ALARMED APPROPRIATELY. THE DISPOSABLE CARTRIDGE WAS NOT RETURNED FOR EVAL. THE EXACT CAUSE OF THE LEAK CANNOT BE DETERMINED. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING SYSTEM ALARMS AND PERFORMING RINSEBACK. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. 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 SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. A CLEAR FLUID LEAK WAS OBSERVED. THE OPERATOR WAS UNSURE OF WHAT TO DO SO TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK 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 8037706

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other