BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1242383 · Received November 21, 2008

    Report

    Report Number
    3003464075-2008-00607
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 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 CLOTTING OF THE EXTRACORPOREAL BLOOD CIRCUIT. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION OCCURRED. AIR ALARMS WERE TRIGGERED FOLLOWING A SALINE BOLUS. THE USER'S GUIDE INCLUDES APPROPRIATE INSTRUCTIONS FOR ADMINISTERING A FLUID BOLUS AND ALSO FOR TROUBLESHOOTING AND RESOLVING AIR ALARMS. NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. FACILITY STAFF HAVE BEEN NOTIFIED. A DIRECT CORRELATION BETWEEN THE 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. IT WAS REPORTED THAT ARTERIAL AIR ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT FOLLOWING ADMINISTRATION OF A FLUID BOLUS. THE ALARMS COULD NOT BE RESOLVED AND THE TREATMENT WAS DISCONTINUED. RINSEBACK WAS NOT PERFORMED DUE TO POSSIBLE CLOTTING RESULTING IN AN ESTIMATED 190CC BLOOD LOSS. 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other