BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA-MIX¿ 600 UNIVERSAL PUMP

    MDR report key: 1901763 · Received November 17, 2010

    Report

    Report Number
    1419106-2010-00020
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS EVALUATION, THE CUSTOMER'S BLACKBOX FILES AND DATABASE WERE RETRIEVED. BLACKBOX FILES ARE AN AUDIT FEATURE OF THE COMPOUNDING OPERATING SOFTWARE THAT CAPTURE AND RECORD ALL IMPORTANT SYSTEM EVENTS FOR LATER ANALYSIS AND TROUBLESHOOTING. THE CUSTOMER USES DIRECT ENTRY, OR MANUAL ENTRY INTO THE SOFTWARE AND DOES NOT USE ANY OTHER PROGRAMS FOR ORDER ENTRY AND TPN CALCULATION. THE USER ORDERED AMOUNTS OF DEXTROSE THAT WERE REASONABLE AS COMPARED TO (B)(4) GUIDELINES; THEREFORE, THIS EVENT WAS NOT A RESULT OF INCORRECTLY ORDERED AMOUNTS. THE DEVICE SOFTWARE DID NOT REPORT ANY VALVE POSITIONING ERRORS DURING COMPOUNDING. A VALVE POSITIONING ERROR WOULD INDICATE THAT THE COMPOUNDER VALVE DID NOT MOVE TO THE CORRECT VALVE POSITION WHEN PUMPING THE PRESCRIBED FORMULA BASED ON THE CONFIGURATION IN PLACE. THE SOFTWARE INSTRUCTED THE USER OF SPECIFIC EVENTS AS INTENDED. THE BLACKBOX DATA SUGGESTS THAT THE USER SWAPPED THE DEXTROSE 70% (D70) WITH STERILE WATER FOR INJECTION (SWFI) DURING THE SETUP OF THE COMPOUNDER. SPECIFICALLY, THE SPIKE END OF THE PRE-ASSEMBLED VALVE SET WAS ATTACHED TO THE INCORRECT INGREDIENTS FOR DEXTROSE AND WATER. AS A RESULT, THE BAGS WERE RECEIVING DEXTROSE ANY TIME WATER WAS ORDERED. THIS RESULTS IN A SIGNIFICANT INCREASE OF DEXTROSE IN THE FINAL BAG. SINCE THE COMPOUNDER WAS CALIBRATED ON DEXTROSE INSTEAD OF WATER THE COMPOUNDER MADE THE APPROPRIATE ADJUSTMENT TO DELIVER DEXTROSE ACCURATELY. THE COMPOUNDER PROVIDES A COSIGNATURE FEATURE THAT CUSTOMERS CAN USE DURING SETUP OF THE COMPOUNDER TO PREVENT IMPROPER SETUP. THE CUSTOMER HAD THIS FEATURE DISABLED. BASED ON OUR EVALUATION, WE CONCLUDE THAT THE EM600 COMPOUNDER PERFORMED AS DESIGNED AND DELIVERED THE REQUESTED VOLUME OF INGREDIENTS. ROOT CAUSE OF THE ADVERSE EVENTS WAS DUE TO USER ERROR. TO PREVENT FURTHER RECURRENCE OF THIS ISSUE AT THIS FACILITY, A DUTY TO WARN LETTER WAS DELIVERED TO THE CUSTOMER. IN THIS LETTER, WE SUGGESTED TWO ACTIONS: ONE, THAT THE COMPOUNDER BE CONFIGURED TO REQUIRE A COSIGNATURE FOR VERIFICATION OF SETUP; TWO, REMEDIAL TRAINING OF OPERATORS TO MITIGATE FUTURE ISSUES. BAXA WILL CONTINUE TO MONITOR THIS TYPE OF REPORT TO DETERMINE IF CORRECTIVE ACTION IS INDICATED IN THE FUTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2010 BAXA WAS NOTIFIED OF THREE PATIENTS WHO WERE OVER DELIVERED DEXTROSE DURING INFUSION OF BAGS COMPOUNDED ON THE EM600 COMPOUNDER. THE DATE OF THE EVENT WAS (B)(6) 2010. TWO OF THE PATIENTS WERE (B)(6) AND THE THIRD PATIENT WAS AN ADULT. FURTHER COMMUNICATION WITH THE FACILITY SHOWED THE REPORT FOR THE ADULT WAS REPORTED IN ERROR AND THERE WAS NO ISSUE WITH THE BAG COMPOUNDED FOR THE ADULT PATIENT. THE TWO (B)(6) THAT WERE REPORTED TO BE AFFECTED BY THE OVER-DELIVERY WILL BE IDENTIFIED AS PAT 1 AND PAT 2. AT THE DATE OF THE EVENT, PAT 1 WAS (B)(6). PAT 1 IS A MALE. DURING INFUSION, THE PATIENT BECAME HYPERGLYCEMIC WITH SERUM LEVELS OF 1555. AS MEDICAL INTERVENTION, TPN INFUSION WAS STOPPED AND A NEW BAG WAS COMPOUNDED. SERUM LEVELS DROPPED TO 1200 AFTER TWO HOURS. HIS BELLY BECAME ENLARGED AND HE WAS TRANSFERRED TO ANOTHER HOSPITAL (UNKNOWN) AS A PRECAUTION SINCE THE REPORTING FACILITY DOES NOT HAVE PEDIATRIC SURGEONS. THE CURRENT STATUS OF PAT 1 IS UNKNOWN. SEVERAL ATTEMPTS WERE MADE TO OBTAIN THIS INFORMATION FROM THE USER FACILITY. AT THE DATE OF THE EVENT, PAT 2 WAS (B)(6). PAT 2 IS A FEMALE. DURING INFUSION, THE PATIENT BECAME HYPERGLYCEMIC WITH SERUM LEVELS OF 662. AS MEDICAL INTERVENTION, TPN INFUSION WAS STOPPED AND A NEW BAG WAS COMPOUNDED. SERUM LEVELS RETURNED TO NORMAL AND THE PATIENT STATUS WAS RESOLVED WITH NO FURTHER ADVERSE REACTIONS. THE TWO (B)(6) BAGS WERE SENT TO A LAB IN (B)(6) FOR ANALYSIS. THE ANALYSIS RESULTS WERE NOT PROVIDED TO BAXA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX¿ 600 UNIVERSAL PUMP PHARMACY COMPOUNDING SYSTEM NEP BAXA CORPORATION 071BR-RS232

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Required Intervention