BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1080438 · Received July 21, 2008

    Report

    Report Number
    3003464075-2008-00321
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 22, 2008
    Report Date
    June 22, 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. THE VENOUS AIR ALARM IS MOST LIKELY DUE TO AIR ENTERING THE CIRCUIT WHILE CONNECTING FOR RINSEBACK. THE CYCLER ALARMED APPROPRIATELY. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR MAKING RINSEBACK CONNECTIONS AND TROUBLESHOOTING AIR ALARMS. 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 INFORMATION 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 DURING RINSEBACK MODE OF A ROUTINE HEMODIALYSIS TREATMENT. EFFORTS TO TROUBLESHOOT THE ALARM AND REMOVE THE AIR WERE UNSUCCESSFUL. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other