BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1192418 · Received October 7, 2008

    Report

    Report Number
    3003464075-2008-00464
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 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 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 REPORTED ALARMS WERE MOST LIKELY THE RESULT OF A LACK OF DIALYSATE FLOW DUE TO A LOOSE CONNECTION MADE BY THE OPERATOR WITH THE DIALYSATE DELIVERY SYSTEM. OCCASIONAL ALARMS DURING HEMODIALYSIS TREATMENTS ARE EXPECTING AND SHOULD NOT RESULT IN BLOOD LOSS IF DEVICE LABELING INSTRUCTIONS ARE FOLLOWED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. 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 FLUID INLET OCCLUSION ALARM OCCURRED AT THE BEGINNING OF A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. CLOTTING OF THE CIRCUIT OCCURRED DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING OF THE ALARM. 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 50 YR Other