BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA-MIX 2400

    MDR report key: 3242852 · Received June 6, 2008

    Report

    Report Number
    1419106-2008-00009
    Event Type
    Injury
    Date Received
    June 6, 2008
    Manufacturer
    BAXA CORP.
    Product Code
    NEP
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: A REVIEW OF THE BLACK BOX DATA FOR THE INITIAL DAILY SETUP AND TPN PRODUCTION UP TO AND INCLUDING TO THE SUBJECT TPN SOLUTIONS WAS CONDUCTED. THE BLACK BOX DATA INDICATED THAT A DOWNWARD FORCE WAS PRESENT DURING THE CALIBRATION OF THE LOAD CELL AT AN INAPPROPRIATE STEP OF THAT PROCESS. SPECIFICALLY, AN ON-SCREEN MESSAGE WAS DISPLAYED INSTRUCTING THE USER TO "EMPTY THE LOAD CELL AND SELECT OK TO CONTINUE." DURING THAT STAGE OF THE LOAD CELL CALIBRATION A DOWNWARD FORCE REMAINED PRESENT WHICH CAUSED THE LOAD CELL TO PERFORM AN INAPPROPRIATE INITIAL TARE. SUBSEQUENT PUMP CALIBRATIONS AND INGREDIENT DELIVERIES WERE DIRECTLY AND PROPORTIONALLY AFFECTED BASED ON THE LOAD CELL CALIBRATION PERFORMED UNDER THIS CONDITION. DURING THE PRODUCTION OF THE PATIENT'S BATCH OF TPN ORDERS, THE USER ACKNOWLEDGED 'LOAD CELL DOES NOT APPEAR TO BE EMPTY' ON-SCREEN WARNINGS FOR EACH SUBJECT TPN SOLUTION, FURTHER SUPPORTING THE CONCLUSION THAT THE LOAD CELL WAS INCORRECTLY CALIBRATED PRIOR TO THE COMPOUNDING OF THE SUBJECT ORDERS. BASED ON THE EVALUATION OF THE AVAILABLE DATA ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE EM2400 COMPOUNDER FUNCTIONED AS DESIGNED BASED ON THE INITIAL CALIBRATION OF THE LOAD CELL. THE COMPOUNDER GENERATED SEVERAL 'LOAD CELL DOES NOT APPEAR TO BE EMPTY' ON-SCREEN WARNINGS THAT THE USER OVERRODE WHICH INDICATE THAT THE LOAD CELL WAS MOST LIKELY INCORRECTLY CALIBRATED. CUSTOMER WAS CONTACTED AND PROVIDED INSTRUCTION ON THE HOW TO PROCEED WHEN 'LOAD CELL DOES NOT APPEAR TO BE EMPTY' WARNINGS ARE GENERATED AND PROVIDED INSTRUCTION ON HOW TO PROCEED DURING LOAD CELL CALIBRATION WHEN THE MESSAGE "EMPTY THE LOAD CELL AND SELECT OK TO CONTINUE" IS DISPLAYED.

    Description of Event or Problem · 1

    ON (B)(4) 2008, BAXA RECEIVED MEDWATCH # 1068680001-2008-0005 INDICATING THAT A PATIENT REPORTED THAT THEIR TPN BAG COMPOUNDED USING THE EXACTA-MIX 2400 COMPOUNDER WAS UNDERWEIGHT. THE PATIENT RECEIVING THE TPN REPORTED THAT THE INFUSION PUMP REPORTED THAT IT HAD APPROXIMATELY 45 MLS LEFT TO BE INFUSED WHEN THE BAG RAN DRY. A NEW BATCH OF BAGS WERE COMPOUNDED AND A LOCAL RN WENT TO THE PATIENT'S HOME WITH AN INFANT SCALE AND WEIGHED ONE OF THE BATCH BAGS THAT WAS NOT USED AND COMPOUNDED ON (B)(6) 2008 AND COMPARED THIS BAG TO THE NEW BATCH OF BAGS COMPOUNDED. THE BAG ON (B)(6) 2008 WEIGHED 3.6 LBS AND THE BAG ON (B)(6) 2008 WEIGHED 4.0 LBS. NO INJURY, ILLNESS, MEDICAL INTERVENTION, LAB TESTS, OR ADDITIONAL MONITORING WERE REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 EXACTA-MIX 2400 NEP BAXA CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1