BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1203002 · Received October 17, 2008

    Report

    Report Number
    3003464075-2008-00499
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 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 AS DIRECTED IN THE USER'S GUIDE. THE DISPOSABLE CARTRIDGE WAS NOT RETURNED FOR EVALUATION. THE EXACT CAUSE OF THE ALARMS CANNOT BE DETERMINED. AIR ALARMS AT THE START OF TREATMENT ARE TYPICALLY DUE TO AIR ENTERING THE SYSTEM WHEN MAKING PATIENT CONNECTIONS OR INADEQUATE AIR REMOVAL DURING PRIME. NO SIMILAR PROBLEMS HAVE BEEN REPORTED SUBSEQUENT TO THIS EVENT. THE USER'S GUIDE IDENTIFIES PROBABLE CAUSES OF THE ALARMS AND PROVIDES ADEQUATE INSTRUCTIONS TO RESOLVE THE ALARMS. A DIRECT CORRELATION 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. ARTERIAL AND VENOUS AIR ALARMS OCCURRED AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT WITH VISIBLE AIR IN THE ARTERIAL LINE. AIR RECOVERY ATTEMPTS WERE UNSUCCESSFUL. TREATMENT WAS ENDED WITHOUT RINSEBACK RESULTING IN AN ESTIMATED BLOOD LOSS OF 100CC. 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 8067708

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other