BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIX SOFTWARE APPLICATION(INCLUDES OE & CM MODULES)

    MDR report key: 2073503 · Received May 2, 2011

    Report

    Report Number
    6000001-2011-03329
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - BUFFALO GROVE
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOGIX QUALITY ENGINEERING TEAM CONDUCTED A LABELING REVIEW FOR THE ISSUE REPORTED. LABEL REVIEW OF THE CUSTOMER WORKSHEETS INDICATES A 10% PRESCRIPTION NOT THE REPORTED 15% DEXTROSE INCLUDED IN THE PRESCRIPTION. THEREFORE, USER ERROR IS SUSPECTED. THE OPERATOR'S MANUAL FOR COMPOUNDER MANAGER (CM) WAS REVIEWED. CHAPTER 1 INDICATES: VERIFY THAT ALL INFORMATION ENTERED IN THE LOGIX OE PROGRAM IS ACCURATE AND CLINICALLY APPROPRIATE. BAXTER HEALTHCARE CORPORATION RECOMMENDS THAT EACH INSTITUTION'S QUALITY ASSURANCE PROGRAM INCLUDE THE FOLLOWING PROCESSES TO ASSURE SAFE USE OF THE SOFTWARE. THE DRUG IDENTIFICATION (ID) FOR A SPECIFIC PRODUCT IN LOGIX CM SOFTWARE MUST MATCH THAT PRODUCT'S UNIQUE IDENTIFIER USED IN THE ORDER ENTRY SYSTEM. THE ROOT CAUSE OF THIS INCIDENT WAS DETERMINED TO BE USE ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PARTIALLY USED BAG OF DEXTROSE IS AVAILABLE AS A SAMPLE. THE PROGRAM REPORTS HAVE BEEN PROVIDED TO BAXTER FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. THIS DEVICE IS 510K EXEMPT.

    Description of Event or Problem · 1

    INITIALLY, THE FACILITY PHARMACY SUPERVISOR NOTIFIED BAXTER REGARDING AN INACCURATE COMPOUNDING OF TOTAL PARENTERAL NUTRITION (TPN) FOR A MALE NEONATE RESULTING IN A HYPOGLYCEMIC EVENT. ACCORDING TO THE PHARMACY SUPERVISOR, THE TPN ORDER INCLUDED: TROPHAMINE, DEXTROSE AND STERILE WATER AND I THINK WE ADDED CALCIUM GLUCONATE. THE FIRST PRODUCT WAS COMPOUNDED ABOUT 8:31 EDT IN THE MORNING AND SENT UP TO THE BABY. THREE BAGS OF TPN WERE COMPOUNDED FOR THIS PATIENT. A NEW ORDER WAS RECEIVED LATE THE MORNING OF (B)(6) 2011 FOR A 15% DEXTROSE SOLUTION. A PARTIAL BAG OF THE TPN WITH 15% DEXTROSE WAS INFUSED. A BAG OF 10% DEXTROSE WAS INFUSED DIRECTLY TO THE BABY RESULTING IN THE GLUCOSE LEVEL BEING RESTORED. STATUS OF THE PATIENT IS CURRENTLY UNKNOWN. ON (B)(6) 2011, THE FACILITY CHECKED A SAMPLE FROM THE AUTOMIX AND SENT IT FOR TESTING; RESULTS ARE UNKNOWN. THIS IS THE FIRST EVENT THAT OCCURRED WITH THIS BABY ON THIS DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGIX SOFTWARE APPLICATION(INCLUDES OE & CM MODULES) SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - BUFFALO GROVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TPN ORDER INCLUDED: TROPHAMINE, DEXTROSE AND STER