BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1100143 · Received August 5, 2008

    Report

    Report Number
    3003464075-2008-00352
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED ALARM AND SUBSEQUENT BLOOD LOSS EVENT IS ATTRIBUTED TO USER ERROR, AS THE OPERATOR DID NOT FOLLOW THE PROPER SET UP INSTRUCTIONS PER THE USER'S GUIDE. FACILITY STAFF HAS BEEN NOTIFIED AND PROVIDED ADDITIONAL TRAINING TO THE OPERATOR. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, THE OPERATOR INADVERTENTLY CONNECTED PATIENT TO INITIATE TREATMENT BEFORE THE SYSTEM PRIME AND ALARMS TEST WERE COMPLETED. WHILE ATTEMPTING RECOVERY, A VENOUS AIR ALARM OCCURRED WITH VISIBLE AIR IN THE SYSTEM. RINSBACK WAS NOT PERFORMED RESULTING IN AN ESTIMATED 50CC BLOOD LOSS. 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 58 YR Other