BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1023316 · Received April 1, 2008

    Report

    Report Number
    3003464075-2008-00142
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. FACILITY STAFF STATED, THAT AIR MAY HAVE ENTERED THE CIRCUIT WHEN INCREASING THE PATIENT'S HEPARIN DOSE AND RESETTING OF THE CYCLER SETTINGS, INDICATING THAT THE CYCLER ALARMED APPROPRIATELY. 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

    AN ARTERIAL AIR ALARM OCCURRED AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT. ATTEMPTS TO ASPIRATE AIR WERE UNSUCCESSFUL. THE PATIENT'S HEPARIN DOSE HAD RECENTLY BEEN DECREASED. RINSEBACK WAS NOT PERFORMED RESULTING IN AN ESTIMATED BLOOD LOSS OF 210CC. 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 8017702

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other