BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROMACRO¿ COMPOUNDER

    MDR report key: 2577093 · Received May 16, 2012

    Report

    Report Number
    1419106-2011-00007
    Event Type
    Injury
    Date Received
    May 16, 2012
    Date of Event
    May 4, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BAXA
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUBMISSION IS BEING RETROACTIVELY SUBMITTED SINCE THE INITIAL SUBMISSION WAS MISTAKENLY SUBMITTED TO THE FDA ELECTRONIC SUBMISSIONS GATEWAY TEST ENVIRONMENT RATHER THAN THE PRODUCTION ENVIRONMENT. DEFECT AWARENESS HAS BEEN CONDUCTED FOR ALL EMPLOYEES SUBMITTING ELECTRONIC SUBMISSIONS TO PREVENT FUTURE RECURRENCE OF THIS ISSUE. IN ADDITION, WE WILL ALSO SEND PAPER COPIES TO ENSURE ALL SUBMISSIONS ARE SUCCESSFULLY RECEIVED PER REGULATORY REQUIREMENTS. IN INVESTIGATING THIS INCIDENT, BAXA TECHNICAL SUPPORT PULLED THE ASSOCIATED DEVICE FILES FOR EVALUATION. THROUGH THIS EVALUATION, WE FOUND THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATIONS. AFTER SUBMITTING THE PATIENT'S TPN ORDER, THE OPERATOR WAS ALERTED BY THE DEVICE SOFTWARE THAT THE ORDER DID NOT CONTAIN A SUFFICIENT AMOUNT OF THE UNIVERSAL INGREDIENT (UI) TO COMPLETE THE FINAL FLUSH OF THE FLUID PATHWAY. IN MOST CASES, THE PREFERRED UI IS STERILE WATER, BUT CAN BE CHANGED BY THE PHARMACIST, AS IS SOMETIMES NECESSARY. IN THIS INSTANCE, THE USER CHOSE DEXTROSE AS THE UI. RECOGNIZING THAT SUCH AN ORDER DID NOT CONTAIN ENOUGH UI TO PROVIDE THE NEEDED FLUSH VOLUME, THE SYSTEM PRESENTED THE USER WITH A WARNING. WHEN THIS OCCURRED, THE SYSTEM ASKED THE OPERATOR HOW THEY WISHED TO RESOLVE THIS ISSUE. FROM THE DEVICE FILES WE CAN SEE THAT THE USER SELECTED TO INCREASE THE UI FLUSH VOLUME BY 15ML. THIS RESULTED IN A TPN BAG CONTAINING 15ML MORE DEXTROSE THAN ORIGINALLY INTENDED. IN ADDITION TO THE INITIAL WARNING, THE COMPOUNDER PROVIDED THE DEVICE OPERATOR WITH A DETAILED REPORT DESCRIBING THE RESULTS OF THE COMPOUNDED BAG. THIS REPORT CLEARLY SHOWS THE TOTAL AMOUNT OF EACH INGREDIENT CONTAINED WITHIN. STANDARD PHARMACY PRACTICE INCLUDES A REVIEW OF THESE REPORTS BY THE PHARMACIST AS A FINAL QUALITY CHECK. THROUGH OUR INVESTIGATION REGARDING THE PERFORMANCE OF THIS PRODUCT, WE HAVE CONCLUDED THAT NO MALFUNCTIONS OCCURRED. THE SYSTEM PERFORMED AS DESIGNED, PROVIDING THE NECESSARY INFORMATION FOR THE HOSPITAL TO MAKE AN INFORMED DECISION REGARDING THE CONTENT OF THE TPN PRODUCED. THE MICROMACRO COMPOUNDER IS DESIGNED TO BE USED BY TRAINED PHARMACISTS AND/OR PHARMACY TECHNICIANS; THEREFORE, WHILE THE COMPOUNDER PROVIDES INCREASED LEVELS OF SAFETY, IT CANNOT REPLACE THE PROFESSIONAL JUDGMENT OF A PHARMACIST. SINCE THIS EVENT, BAXA TECHNICAL SUPPORT HAS ASSISTED THE CUSTOMER WITH SETTING THEIR DEVICE CONFIGURATIONS TO MATCH BAXA RECOMMENDATIONS, AS WELL AS APPLYING A SECURITY SETTING REGARDING THE USE OF THE UNIVERSAL INGREDIENT. METHOD: COMPUTER SOFTWARE PERFORMANCE TEST CONDUCTED. DEVICE-TO-HUMAN INTERACTIONS TESTING. RESULTS: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE OPERATED ACCORDING TO SPECIFICATIONS. NO DEVICE FAILURE. USER ERROR CAUSED EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXA BECAME AWARE OF AN INCIDENT INVOLVING THE USE OF OUR MICROMACRO COMPOUNDER. THE MICROMACRO COMPOUNDER IS A PHARMACY TOOL WHICH PROVIDES AUTOMATED COMPOUNDING OF BOTH LARGE-VOLUME AND MICRO INGREDIENTS FOR SOLUTIONS SUCH AS PATIENT-SPECIFIC TOTAL PARENTERAL NUTRITION (TPN), HYDRATION AND CARDIOPLEGIA SOLUTIONS. ON THE ABOVE MENTIONED DATE, BAXA LEARNED OF AN INCIDENT IN WHICH A PATIENT WAS INFUSED WITH A TPN THERAPY BAG CONTAINING HIGHER THAN EXPECTED LEVELS OF DEXTROSE. ACCORDING TO THE USER FACILITY, THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 1200, REQUIRING MEDICAL INTERVENTION IN THE FORM OF INSULIN. AFTER INTERVENTION, THE PATIENT'S GLUCOSE LEVELS DROPPED TO 360, AND REMAINED STABLE THEREAFTER. NO LONG TERM PATIENT INJURY OR ILLNESS HAS BEEN ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROMACRO¿ COMPOUNDER MICROMACRO LHI BAXA 071AR-RS232 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening| R