BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1202797 · Received October 15, 2008

    Report

    Report Number
    3003464075-2008-00491
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 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 AS INSTRUCTED IN THE USER'S GUIDE. THE DISPOSABLE CARTRIDGE WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THE REPORTED LEAK CANNOT BE CONFORMED. THE USER'S GUIDE PROVIDES ADEQUATE WARNINGS TO OBSERVE FOR POTENTIAL LEAKS AND TO DISCONTINUE TREATMENT IF A LEAK IS OBSERVED. A DIRECT CORELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. 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 CLEAR FLUID LEAK OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR ENDED TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS EVENT 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 8057704

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other