BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    MDR report key: 1033608 · Received April 24, 2008

    Report

    Report Number
    1419106-2008-00003
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 22, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S SUBSEQUENT INVESTIGATION REVEALED THAT DURING SET UP OF THE COMPOUNDER, THE TECH MISTAKENLY READ THE PHYSICIAN'S ORDER AS ORDERING 70% DEXTROSE INSTEAD OF THE 10% DEXTROSE ON THE PHYSICIAN'S ORDER. CUSTOMER ALSO REPORTED THAT TWO OTHER PHARMACIST VERIFICATION CHECKS INADVERTENTLY MISSED THE DISCREPANCY BETWEEN THE 10% DEXTROSE ON THE PHYSICIANS ORDER AND 70% DEXTROSE HUNG ON THE COMPOUNDER. CUSTOMER REPORTED TO BAXA THAT THEY DID NOT FOLLOW THEIR OWN PROCESS OF HYDRATION COMPOUNDING. CUSTOMER INDICATED THAT WHEN A COMMERCIALLY AVAILABLE PRODUCT (10% DEXTROSE) IS AVAILABLE, THEY ARE TO USE THAT COMMERCIAL PRODUCT BECAUSE THEY ONLY HANG 70% DEXTROSE ON THE COMPOUNDER AND USE THE COMPOUNDER IN THE EVENT A PHYSICIAN REQUESTS A NON-COMMERCIALLY AVAILABLE DEXTROSE SOLUTION. IN ORDER TO INVESTIGATE THE ISSUE FURTHER, THE ADDITIONAL FOLLOWING ITEMS WERE EVALUATED: AN EVAL OF THE EM2400 MIXCHECK AND A COPY OF THE PHYSICIAN'S ORDER INDICATED THAT THE COMPOUNDER CLEARLY SHOWED THAT 70% DEXTROSE WAS HUNG ON THE COMPOUNDER AND THAT THE PHYSICIAN HAD REQUESTED 10% DEXTROSE. EM2400 COMPOUNDER DATABASE DATA: THE EM2400 DATABASE SHOWS ORDERS, INGREDIENT SETTINGS (FORMULARY, ORDER TEMPLATES) IN PLACE AT THE TIME OF DATABASE RETRIEVAL. RESULTS OF EVAL: THE DATABASE FOR THE EM2400 COMPOUNDER WAS EVALUATED BY BAXA TECHNICAL SUPPORT. THE REVIEW OF THE DATABASE SHOWED THAT THE COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE VOLUMES OF THE REQUESTED INGREDIENT. BASED ON AN EVAL OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE EM2400 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE REQUESTED VOLUME OF INGREDIENTS. THIS EVENT WAS CAUSED BY THE USER INCORRECTLY READING THE PHYSICIANS ORDER. IT WAS ALSO DETERMINED THAT THE EM2400 MIXCHEK THAT IS PRODUCED WITH THE ORDER OF THE HYDRATION BAG CLEARLY INDICATE THE 70% DEXTROSE WAS HUNG ON COMPOUNDER AND 10% DEXTROSE WAS REQUESTED ON THE PHYSICIANS ORDER. PHARMACIST VERIFICATION OF THE MIXCHECK REPORT FAILED TO IDENTIFY THE INCORRECT AMOUNT OF DEXTROSE THAT WAS PRESENT WITHIN THE HYDRATION BAG. CUSTOMER IS CURRENTLY WORKING WITH A BAXA APPLICATION SPECIALIST FOR A SOLUTION FOR THE PREVENTION OF FUTURE INCIDENTS SUCH AS THIS BY UTILIZING SOFTWARE TOOLS THAT THEY HAVE AVAILABLE TO THEM WITHIN THEIR PHARMACY PRACTICE.

    Description of Event or Problem · 1

    IN 2008, BAXA WAS NOTIFIED OF AN ADVERSE EVENT. THE CUSTOMER REPORTED THAT THE PT WAS INFUSED WITH A TPN SOLUTION FOR APPROX 24 HOURS WHEN THE PT EXPERIENCED ELEVATED SUGAR LEVELS THAT RESULTED IN BRAIN HEMORRHAGING. THE PT WAS SUBSEQUENTLY TRANSFERRED TO CRITICAL CARE AND PUT ON LIFE SUPPORT. THE CUSTOMER'S SUBSEQUENT INVESTIGATION REVEALED THAT THE USER ENTERING THE TPN ORDER INTO THE EM2400 COMPOUNDER SOFTWARE MISTAKENLY READ THE PHYSICIAN ORDER. THE PHYSICIANS ORDER REQUIRED 10% DEXTROSE AND THE HYDRATION BAG WAS COMPOUNDED WITH 70% DEXTROSE. PT STATUS AS OF THE FOLLOWING MONTH: PT IS STABLE AND OFF LIFE SUPPORT. CUSTOMER REPORTS THAT BRAIN DAMAGE IS POSSIBLE, BUT THE EXTENT OF THE DAMAGE IS STILL UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 COMPOUNDING SYSTEM EM2400 COMPOUNDER LHI BAXA CORP. 2400-D2R

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R