BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMIX 3+/AS COMPOUNDER (REFURBISHED)

    MDR report key: 2053363 · Received April 13, 2011

    Report

    Report Number
    6000001-2011-02816
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PATIENT WAS INVOLVED, (B)(4), WHO EXPERIENCED TWO EVENTS WHICH OCCURRED ON THE SAME DATE AT DIFFERENT TIMES. THIS REPORT REFERS TO THE FIRST EVENT. ADDITIONAL INFORMATION: THE BAXTER ENGINEERS HAD SPOKEN WITH THE FACILITY PHARMACIST (RPH) ON (B)(6) 2011 AND DETERMINED, PER THE INFORMATION CURRENTLY AVAILABLE, THE PRESCRIPTION INCLUDED DEXTROSE 15%, HOWEVER, THE WORKSHEETS INDICATED THE TOTAL PARENTERAL NUTRITION (TPN) WAS COMPOUNDED WITH DEXTROSE 10%, VOLUME 58 ML TO BE INFUSED OVER 24 HOURS AT A RATE OF 2.4ML PER HOUR. THREE BAGS WERE COMPOUNDED AT 08:31 ON (B)(6) 2011. REPORTEDLY, THE EVENT OCCURRED ON (B)(6) 2011. ONE BAG OF TPN WAS INFUSED RESULTING IN THE BABY EXPERIENCING A HYPOGLYCEMIC EVENT. THE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). EVALUATION COULD NOT CONFIRM OR DUPLICATE THE REPORTED PROBLEM FOR THE COMPOUNDER INCORRECTLY COMPOUNDED A TPN ORDER. THE COMPOUNDER IS DELIVERING AS DESIGNED. THE DEVICE PASSED ALL ACCURACY AND OTHER TESTING. THE ROOT CAUSE IS UNDETERMINED. A SERVICE HISTORY REVIEW REVEALED NO EVENTS RELATED TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE BAXTER PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS PRODUCT IS 510K EXEMPT.

    Description of Event or Problem · 1

    THE FACILITY PHARMACY SUPERVISOR NOTIFIED BAXTER REGARDING AN INACCURATE COMPOUNDING OF TOTAL PARENTERAL NUTRITION (TPN) FOR A MALE NEONATE RESULTING IN A HYPOGLYCEMIC EVENT (VALUES NOT REPORTED). ACCORDING TO THE PHARMACY SUPERVISOR, THE TPN ORDER INCLUDED: TROPHAMINE, DEXTROSE AND STERILE WATER AND, I THINK WE ADDED CALCIUM GLUCONATE. THE FIRST PRODUCT WAS COMPOUNDED ABOUT 8:31 EDT IN THE MORNING AND SENT UP TO THE BABY. THREE BAGS OF TPN WERE COMPOUNDED FOR THIS PATIENT. A NEW ORDER WAS RECEIVED LATE THE MORNING OF (B)(6) 2011 FOR A 15% DEXTROSE SOLUTION. A PARTIAL BAG OF THE TPN WITH 15% DEXTROSE WAS INFUSED. STATUS OF THE PATIENT IS CURRENTLY UNKNOWN. A BAG OF 10% DEXTROSE WAS INFUSED DIRECTLY TO THE BABY RESULTING IN THE GLUCOSE LEVEL BEING RESTORED. ON (B)(6) 2011, THE FACILITY CHECKED A SAMPLE FROM THE AUTOMIX AND SENT IT FOR TESTING; RESULTS ARE UNKNOWN. THE PARTIALLY USED BAG OF DEXTROSE IS AVAILABLE AS A SAMPLE. A SWAP OF THE DEVICE HAS BEEN ARRANGED. THE FACILITY USES LOGIX SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMIX 3+/AS COMPOUNDER (REFURBISHED) SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TOTAL PARENTERAL NUTRITION (TPN)