BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1942510 · Received December 22, 2010

    Report

    Report Number
    3003464075-2010-00146
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 28, 2010
    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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK OF THE PATIENT'S BLOOD DUE TO AIR VISIBLE IN THE EXTRACORPOREAL BLOOD CIRCUIT. THE CYCLER ALARMED APPROPRIATELY TO THE PRESENCE OF AIR. AIR ALARMS AT THE END OF TREATMENT ARE MOST LIKELY THE RESULT OF THE OPERATOR INTRODUCING AIR INTO THE DISPOSABLE CIRCUIT WHILE MAKING PATIENT CONNECTIONS FOR RINSEBACK. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR TROUBLESHOOTING AIR ALARMS AND MAKING PATIENT CONNECTIONS. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A VENOUS AIR ALARM OCCURRED AT THE END OF A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS NOT PERFORMED DUE TO VISIBLE AIR IN THE LINE, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT WAS RESTARTED ON EPOGEN. NO OTHER 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-B 0067710

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other