BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1030078 · Received April 16, 2008

    Report

    Report Number
    3003464075-2008-00170
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE EXTRACORPOREAL CIRCUIT DUE TO THE AMOUNT OF TIME SPENT CORRECTING THE PT CONNECTIONS AND TROUBLESHOOTING THE ALARM. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR MAKING PT CONNECTIONS. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED AND PROVIDED ADDITIONAL TRAINING REGARDING PT CONNECTIONS. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT AN ARTERIAL AIR ALARM OCCURRED WHILE THE OPERATOR WAS CORRECTING AN ERROR MADE WITH THE PT CONNECTIONS. THE CIRCUIT CLOTTED DUE TO THE AMOUNT OF TIME SPENT TROUBLESHOOTING THE ALARM AND MAKING THE PROPER PT CONNECTIONS, 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 8017706

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other