BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXACTA-MIX 2400

    MDR report key: 413203 · Received August 23, 2002

    Report

    Report Number
    1419106-2002-00001
    Event Type
    Death
    Date Received
    August 23, 2002
    Date of Event
    August 10, 2002
    Report Date
    August 23, 2002
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL CALLED BAXA TO REPORT AN ERROR THEY MADE WHILE USING THE EM-2400 TPN PHARMACY COMPOUNDING SYSTEM. HOSPITAL REPORTED THAT ON FRIDAY IN 2002, A PHARMACY TECHNICIAN CHANGED THE UNIVERSAL INGREDIENT FROM WATER TO DEXTROSE AND DID NOT CHANGE IT BACK TO WATER; WHEN THE WEEKEND TECHNICIAN CAME IN SATURDAY TO PREPARE TPN BAGS THE UNIVERSAL INGREDIENT WAS DEXTROSE INSTEAD OF WATER AND THE CHANGE WAS NOT ACKNOWLEDGED OR CORRECTED BY THE TECHNICIAN. DURING THE DAY THEY HAD TO PREPARE SEVERAL ADULT AND PEDIATRIC TPN'S. ONE OF THE TPN ORDERS DID NOT HAVE ENOUGH OF THE UNIVERSAL INGREDIENT IN THE FORMULA TO PROVIDE AN ADEQUATE FLUSH. WHEN THIS OCCURS, THE SYSTEM WILL PROMPT THE USER WITH A QUESTION REGARDING HOW TO RESOLVE THE FLUSH REQUIREMENT. IN THIS CASE THE SYSTEM RECOGNIZED THAT TO COMPLETE THE LINE FLUSH IT NEEDED AN ADD'L 15ML OF THE UNIVERSAL INGREDIENT AND DISPLAYED "ADD'L 15.00 ML OF DEXTROSE REQUIRED FOR FLUSH" "INCREASE INGREDIENT VOLUME?" THE TECHNICIAN CHOSE TO ANSWER YES - INCREASE INGREDIENT VOLUME, WHICH RESULTED IN THE TPN BAG HAVING ADD'L DEXTROSE ADDED TO THE BAG TO PROVIDE THE NEEDED FLUSH VOLUME. IN MOST CASES THE PREFERRED UNIVERSAL INGREDIENT IS WATER, BUT IT CAN BE CHANGED BY THE PHARMACIST IF NECESSARY. THE BAXA COMPOUNDING SYSTEM HAS ALSO BEEN DESIGNED TO PRINT A REPORT DESCRIBING THE RESULTS OF COMPOUNDING FOR EACH BAG, AT THE TIME THE BAG IS PRODUCED. THIS REPORT STATES WHETHER THE USER HAS RESPONDED TO PROMPTS FROM THE EQUIPMENT, AS WOULD BE THE CASE IN THE UNIVERSAL INGREDIENT FLUSH ADDITION. STANDARD PRACTICE WOULD INCLUDE A REVIEW OF THIS REPORT BY THE PHARMACIST AS A FINAL QUALITY CHECK. THE PT RECEIVED ADD'L DEXTROSE AND TO THE BEST OF THE CO'S UNDERSTANDING DIED THE SAME DAY INFUSED WITH THE TPN SOLUTION. ALTHOUGH THE PT WAS VERY PREMATURE, THE DEATH DID CAUSE THEM TO INVESTIGATE ALL POSSIBLE CAUSES AND CONTRIBUTING FACTORS. THROUGH THEIR INVESTIGATION THEY DISCOVERED THE ERROR OF ADDING ADD'L DEXTROSE, WHICH THEY FEEL MAY HAVE CONTRIBUTED TO THE PT' S COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 PHARMACY COMPOUNDING SYSTEM LHI BAXA CORP. EM-2400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Death