BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1251762 · Received December 3, 2008

    Report

    Report Number
    3003464075-2008-00636
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 9, 2008
    Report Date
    November 9, 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 EFFLUENT 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 SYS ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED AND REVIEWED THE EVENT WITH THE OPERATOR. 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. AFTER PRIMING THE EXTRACORPOREAL CIRCUIT FOR A ROUTINE HEMODIALYSIS TREATMENT, THE OPERATOR INADVERTENTLY LEFT THE EFFLUENT LINE CONNECTED TO THE SALINE BAG, CAUSING THE SALINE BAG TO FILL AND BURST AFTER TREATMENT WAS STARTED. RINSEBACK WAS NOT PERFORMED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALSYS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 8077721

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other