BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1160466 · Received September 12, 2008

    Report

    Report Number
    3003464075-2008-00424
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 16, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS EVENT AND VENOUS AIR ALARMS ARE ATTRIBUTED TO USER ERROR AS THE OPERATOR INADVERTENTLY FAILED TO CLAMP THE SALINE LINE AT THE START OF TREATMENT. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR PT CONNECTIONS AND TREATMENT PROCEDURES. 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. A VENOUS AIR ALARM OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR INADVERTENTLY LEFT THE SALINE LINE UNCLAMPED ALLOWING AIR TO ENTER THE CIRCUIT. RINSEBACK WAS NOT PERFORMED DUE TO THE AMOUNT OF AIR, 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 8037703

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other