BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1210288 · Received October 21, 2008

    Report

    Report Number
    3003464075-2008-00508
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK DUE TO THE AMOUNT OF AIR IN THE CIRCUIT. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVALUATION. THE EXACT CAUSE OF THE ALARMS CANNOT BE DETERMINED, BUT WERE MOST LIKELY DUE TO SET UP DIFFICULTIES AND PROBLEMS WITH THE PATIENT'S VASCULAR ACCESS NEEDLES. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. THE OPERATOR REPORTED HAVING UNSPECIFIED TROUBLES WITH THE PATIENT'S VASCULAR ACCESS NEEDLES, AND SET UP OF A ROUTINE HEMODIALYSIS TREATMENT. HIGH VENOUS PRESSURE AND OTHER UNSPECIFIED ALARMS OCCURRED DURING THE TREATMENT. RINSEBACK WAS NOT PERFORMED DUE TO AIR IN THE CIRCUIT, 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 8057703

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other