BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1101487 · Received August 6, 2008

    Report

    Report Number
    3003464075-2008-00357
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 9, 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 BLOOD LOSS EVENTS ARE ATTRIBUTED TO USER ERROR AS THE OPERATOR DID NOT FOLLOW THE PROPER INSTRUCTIONS IN THE USER'S GUIDE. FACILITY STAFF ATTRIBUTED THE PT'S DIFFICULTIES WITH ADVANCING TO RINSEBACK MODE TO USER ERROR. FACILITY STAFF WILL REVIEW THE EVENTS WITH THE OPERATOR AND PROVIDE ADD'L TRAINING REGARDING RINSEBACK PROCEDURES. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. DURING TWO ROUTINE HEMODIALYSIS TREATMENTS, THE OPERATOR WAS UNABLE TO ADVANCE TO RINSEBACK MODE. ATTEMPTS TO PERFORM MANUAL RINSEBACK WERE UNSUCCESSFUL AS THE OPERATOR INADVERTENTLY DID NOT FOLLOW THE REQUIRED STEPS. AN ESTIMATED 190CC BLOOD LOSS OCCURRED FOR EACH TREATMENT. 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 78 YR Other