BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTAMIX 2400 COMPOUNDER

    MDR report key: 2834084 · Received November 15, 2012

    Report

    Report Number
    1419106-2012-00019
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER TECHNICAL SUPPORT CONTACTED THE CUSTOMER AND ASKED FOR A COPY OF THEIR DATABASE IN ORDER TO REVIEW IT IN AN ATTEMPT TO DETERMINE A WAY TO PREVENT A REOCCURRENCE OF THIS ISSUE. WAITING FOR APPROVAL FROM THE PHARMACY DEPARTMENT MANAGER. THE USER FACILITY CHOSE NOT TO PROVIDE A COPY OF THEIR DATABASE. THE CUSTOMER STATED THEY HAD FIXED THE PROBLEM BY MAKING THE NEW TEMPLATE UNAVAILABLE TO THE WRONG PATIENT TYPE. IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE CONTENT OF THIS REPORT, A FOLLOW-UP MDR WILL BE SUBMITTED. NO DEVICE DEFECT OR MALFUNCTION INVOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A CUSTOMER CALLED IN TO STATE THAT THEY HAD A PATIENT INVOLVEMENT WHERE THE WRONG TOTAL PARENTERAL NUTRITION (TPN) TEMPLATE WAS SELECTED AND THE TPN SOLUTION WAS ADMINISTERED TO THE PATIENT OVER A THREE DAY PERIOD. THE CUSTOMER USED A EM2400 EXACTAMIX COMPOUNDER, USING ABACUS VERSION 2.0.102 SOFTWARE TO PREPARE THE TPN SOLUTION FOR THE PATIENT. (B)(4). THE PATIENT WAS UNDER DELIVERED POTASSIUM, SODIUM, MAGNESIUM AND PHOSPHATE. THE TPN WAS ADMINISTERED (B)(6) 2012. THE TEMPLATE THAT WAS USED HAD THE ORDERING OF INGREDIENTS MEQ/- WHEN THE PATIENT WAS SUPPOSED TO GET THE TEMPLATE WITH THE INGREDIENTS ORDERING OF MEQ/KG/DAY. THE TEMPLATE IS SELECTED BY THE USER, BASED ON THE PATIENT TYPE (ADULT, NEONATAL, ETC.). THE PATIENT STATUS IS REPORTED TO BE STABLE AFTER THE ADMINISTRATION OF A MODIFIED TPN. THE MODIFIED TPN INCREASED THE DELIVERY OF POTASSIUM, SODIUM, MAGNESIUM AND PHOSPHATE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND NO OTHER PATIENTS WERE INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX 2400 COMPOUNDER EM 2400 NEP BAXA CORPORATION EM2400

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention