BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1063181 · Received June 20, 2008

    Report

    Report Number
    3003464075-2008-00270
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY STAFF REPORTED THE BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PATIENT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE ARTERIAL AIR ALARM IS NOT KNOWN, BUT IS UNLIKELY CARTRIDGE RELATED SINCE IT OCCURRED IN THE MIDDLE OF THE TREATMENT. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. AN ARTERIAL AIR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT THAT COULD NOT BE RESOLVED BY THE OPERATOR. RINSEBACK WAS NOT PERFORMED DUE TO SUSPECTED CLOTTING OF THE CIRCUIT, 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 8027707

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other