BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1221889 · Received November 4, 2008

    Report

    Report Number
    3003464075-2008-00548
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO USER ERROR AS THE OPERATOR INADVERTENTLY LEFT THE VENOUS LINE CONNECTED TO THE SALINE BAG WHEN ENTERING TREATMENT MODE. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR MAKING PT CONNECTIONS WHEN ENTERING TREATMENT. 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 ADDITIONAL 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. AT THE BEGINNING OF A ROUTINE HEMODIALYSIS TREATMENT, THE OPERATOR INADVERTENTLY LEFT THE VENOUS LINE CONNECTED TO THE SALINE BAG, CAUSING IT TO FILL WITH BLOOD AS THE TREATMENT WAS STARTED. RINSEBACK WAS NOT PERFORMED 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 8077717

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other