BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIX

    MDR report key: 2240052 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23409
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE HAS NO 510(K) NUMBER, AS IT IS CLASS II EXEMPT. EVALUATION SUMMARY: BAXTER NUTRITION TECHNICAL SERVICES EVALUATED THE SOFTWARE. REVIEW OF THE WINDOWS APPLICATION EVENT VIEWER REVEALED THAT THE "AUTOGROW" FEATURE OF SQL SERVER WAS IN THE PROCESS OF INCREASING THE SIZE OF THE LOGIX OE DATABASE. WHEN THE AUTOGROW FEATURE IS ACTIVE, IT CAN RESULT IN THE REPORTED BEHAVIOR. THE PC HOSTING THE LOGIX OE DATABASE WAS REBOOTED AND THE LOGIX OE DATABASE WAS BACKED UP IN AN ATTEMPT TO PRE-EMPT THE AUTOGROW FEATURE AND RETURN THE LOGIX SYSTEM TO AN OPERATIONAL STATE. THIS WAS SUCCESSFUL, AND LOGIX OE WAS ABLE TO SUCCESSFULLY EXPORT TPN ORDERS TO LOGIX CM. THE PROBLEM WAS RESOLVED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT LOGIX COMPOUNDING SOFTWARE WAS SENDING AUTHORIZED ORDERS TO "EXPORT ERROR" STATUS. THE ORDERS WERE APPEARING IN BOTH THE "ORDERS" TAB AND "ERRORS" TAB OF THE MAIN PANE. THE FACILITY WAS UNABLE TO SUCCESSFULLY TRANSFER ANY ORDERS FROM LOGIX OE TO LOGIX CM. ON A SUBSEQUENT ATTEMPT TO AUTHORIZE AN ORDER IN LOGIX OE, A "MICROSOFT. NET FRAMEWORK" "LOGIX OE APPLICATION EXCEPTION" ERROR MESSAGE WAS DISPLAYED. THIS CONDITION CAN LEAD TO INCORRECT COMPOUNDING OR INCORRECT LABELING OF COMPOUNDING MATERIAL. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGIX SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1