BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTAMIX® 1200

    MDR report key: 2454398 · Received February 16, 2012

    Report

    Report Number
    1419106-2012-00002
    Event Type
    Death
    Date Received
    February 16, 2012
    Date of Event
    December 4, 2011
    Report Date
    December 16, 2011
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. CONCLUSION: DEVICE OPERATED ACCORDING TO SPECIFICATIONS, USER ERROR CAUSED EVENT. GLOSSARY OF TERMS: ABACUS: ABACUS IS A (B)(6)-BASED ORDER ENTRY SOFTWARE FOR COMPREHENSIVE TOTAL PARENTERAL NUTRITION (TPN) CALCULATIONS AND LABEL PRINTING. EXACTAMIX 2400 COMPOUNDER: THE EXACTAMIX 2400 COMPOUNDER (EM2400) IS A 24-PORT AUTOMATED COMPOUNDING DEVICE FOR MULTI-SOURCE FLUID MIXING OF BOTH MACRO AND MICRO INGREDIENTS FOR TPN COMPOUNDING. WARNING LIMITS: TERM USED IN ABACUS TO DESCRIBE PRESET DOSING THRESHOLDS, AND IS A FEATURE THAT ALLOWS USERS TO CREATE ALERTS FOR POTENTIAL DOSING ERRORS DURING ORDER-ENTRY AND/OR CALCULATION. THE ABACUS SOFTWARE HAS A SPECIFIC SET OF "BAXA ONLY" LIMITS FOR THE PURPOSE OF PREVENTING GROSS DOSING ERRORS FOR MOST TOTAL PARENTERAL NUTRITION INGREDIENTS, AS WELL AS INSTITUTIONAL LIMITS FOR THE PURPOSE OF HELPING USERS ESTABLISH A FIRST LINE OF DOSING ERROR PROTECTION THAT IS SPECIFIC TO THE NEEDS OF THE CUSTOMER. MIXCHECK REPORT: THE MIXCHECK REPORT PROVIDES DETAILS ABOUT THE COMPOUNDING PROCESS FOR AN ORDER. IT REPORTS INFORMATION INCLUDING THE EXPECTED BAG WEIGHT, MEASURED BAG WEIGHT, ORDERED INGREDIENTS AND VOLUMES, AND MANUAL ADDITIONS THAT ARE REQUIRED. OUR TECHNICAL SUPPORT TEAM RECEIVED ABACUS DATABASES AND COMPOUNDER DATABASE FILES RELATED TO THE REPORTED EVENT. THE CUSTOMER USED ABACUS TO CALCULATE THE PATIENT'S TPN ORDER AND COMPOUNDED THE BAG USING THE EM2400 COMPOUNDER. THE DENOMINATOR FOR THE RATE VALUE IN THE ABACUS WAS CHANGED FROM ML/HOUR TO KG/DAY DURING ORDER INPUT. WARNING LIMITS WERE TRIGGERED FOR THE ORDER BUT WERE OVERRIDDEN BY THE PHARMACIST. NO RATIONALE WAS PROVIDED FOR THE OVERRIDE AND THE ORDER WAS COMPLETED. A REVIEW OF THE COMPOUNDER DATABASE AND MIXCHECK REPORTS SHOWED THE COMPOUNDER COMPLETED THE ORDER PER THE PATIENT FILE FROM ABACUS. OUR INVESTIGATION CONCLUDES THAT BOTH DEVICES INVOLVED OPERATED AS INTENDED AND THE EVENT WAS DUE TO USER ERROR. AS CORRECTION, THE TEMPLATE IN QUESTION HAS BEEN MADE UNAVAILABLE TO USERS AND THE APPROPRIATE PATIENT TYPES WERE SET UP TO PREVENT FUTURE RECURRENCE.

    Additional Manufacturer Narrative · 1

    BAXA MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE FACILITY ONCE BECOMING AWARE OF THE ADVERSE EVENT. BECAUSE THE FACILITY WAS UNWILLING TO PROVIDE THE INFORMATION BEING REQUESTED, A REGISTERED LETTER WAS SENT ON 02/08/2012 TO THE RISK MANAGEMENT MANAGER AND THE DIRECTOR OF PHARMACY OPERATIONS REMINDING THEM OF THEIR CONTRACTUAL AGREEMENT TO COOPERATE WITH OUR INQUIRIES FOR ADDITIONAL INFORMATION. WE REQUESTED DATABASES AND REPORTS FOR THE BAXA SYSTEMS THAT ARE SUSPECTED TO BE INVOLVED IN THIS EVENT WITH A DEADLINE OF 02/24/2012. WE ARE WAITING TO RECEIVE THE TECHNICAL INFORMATION IN ORDER TO PERFORM A FORMAL INVESTIGATION INTO THIS REPORT. A FOLLOW-UP MDR WILL BE FILED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, BAXA BECAME AWARE OF AN ADVERSE EVENT THAT RESULTED IN PATIENT DEATH, WHICH WAS REPORTED THROUGH FDA'S MEDWATCH PROGRAM. REPORT (B)(4) WAS RECEIVED VIA POSTAL MAIL FROM THE DIVISION OF POSTMARKET SURVEILLANCE. MEDWATCH DESCRIPTION: "PERFORMED AN INTERNAL CHART REVIEW BECAUSE PATIENT'S DEATH WAS NOT EXPECTED AND THE SUDDEN DETERIORATION IN THIS PATIENT'S CONDITION REVEALED AN ERROR THAT AN INCORRECT DOSING OF ELECTROLYTES RESULTED IN ELECTROLYTE ABNORMALITIES SEVERE ENOUGH TO CAUSE DEATH. INTERNAL INVESTIGATION REVEALED DATA WAS INCORRECTLY ENTERED INTO THE COMPOUNDING MACHINE. THE RATE FIELD CONSISTS OF THE VALUE, NUMERATOR, AND DENOMINATOR. THE ERROR WAS MADE IN THE DENOMINATOR FIELD WHERE THE DROP DOWN SELECTION WAS CHANGED FROM THE DEFAULT OF /HOUR TO /KG/DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX® 1200 SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXA CORPORATION 2400-M

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Death