BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIX

    MDR report key: 2162407 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11912
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOGIX IS A SOFTWARE PROGRAM, NOT A DEVICE. THIS IS 510(K) EXEMPT CLASS II. A FOLLOW-UP MDR WILL BE SENT WHEN THE RESULTS OF SOFTWARE EVALUATION ARE COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOGIX VERIFICATION AND VALIDATION TEAM INVESTIGATED THE COMPLAINT AND THE CUSTOMER?S REPORTED CONDITION IS CONFIRMED. AFTER INVESTIGATING THE ISSUE, THE LOGIX SOFTWARE CHANGE CONTROL BOARD (SCCB) DETERMINED THE CAUSE AS USER ERROR. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. NO CORRECTION WILL BE PERFORMED FOR THIS ISSUE AS THE SOFTWARE FUNCTIONS TO SPECIFICATIONS. A LABELING REVIEW WAS PERFORMED AND THE MANUAL WAS FOUND TO BE ADEQUATE AND SUFFICIENT. SOFTWARE VERSION LOGIX 1.1.2.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED AN EMAIL REGARDING THE LOGIX SOFTWARE. THE CUSTOMER REPORTED WHEN ADDING INGREDIENTS LIKE INTRALIPID 30% IN AN ORDER THAT IS NOT IN THE TEMPLATE, THE DEFAULT IS ALWAYS G PER BAG EVEN THOUGH THE PRIMARY INGREDIENT IS IN A DIFFERENT UNIT OF MEASURE, LIKE G PER KG PER BAG. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, INJURY, OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1