BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYTEM ONE

    MDR report key: 1080435 · Received July 21, 2008

    Report

    Report Number
    3003464075-2008-00323
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 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 COMPLETING RINSEBACK IN A TIMELY MANNER AS DIRECTED IN THE USER'S GUIDE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OCCURRED. AIR ALARMS DURING RINSEBACK ARE MOST LIKELY THE RESULT OF THE OPERATOR INTRODUCING AIR INTO THE DISPOSABLE CIRCUIT WHILE MAKING PT CONNECTIONS FOR RINSEBACK. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS AND MAKING PT CONNECTIONS. 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 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. AN ARTERIAL AIR ALARM OCCURRED WHILE ENTERING RINSEBACK MODE OF A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. THE CIRCUIT CLOTTED DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARM, PREVENTING RINSEBACK FROM BEING COMPLETED, AND 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 SYTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170 8037702

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other