BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1140946 · Received August 28, 2008

    Report

    Report Number
    3003464075-2008-00406
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 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 IN A TIMELY MANNER. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. THE DISPOSABLE CARTRIDGE WAS NOT AVAILABLE FOR EVAL. THE EXACT CAUSE OF THE AIR ALARMS COULD NOT BE DETERMINED BUT UNLIKELY RELATED TO DISPOSABLE OR EQUIPMENT. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED AND REVIEWED THE EVENT WITH THE OPERATOR. NO FURTHER SIMILAR PROBLEMS WERE REPORTED. 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. VENOUS AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT, WHICH THE OPERATOR WAS ABLE TO RECOVER FROM. ARTERIAL AIR ALARMS THEN OCCURRED WHICH COULD NOT BE RESOLVED. RINSEBACK WAS NOT PERFORMED DUE TO CLOTTING OF THE CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190C. 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 50 YR Other