BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTAMIX 2400 COMPOUNDER

    MDR report key: 2093959 · Received April 25, 2011

    Report

    Report Number
    1419106-2011-00004
    Event Type
    Other
    Date Received
    April 25, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 26, 2011
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF DATABASE BLACK BOX FILES WAS REVIEWED. THE DEVICE OPERATED AS INTENDED, THE USER HUNG AND SCANNED DIFFERENT INGREDIENTS. AS A RESULT OF THE INCORRECT INGREDIENT SELECTION, THE PATIENTS RECEIVED 4MEQ OF K ACETATE INSTEAD OF 2MEQ OF K ACETATE.

    Description of Event or Problem · 1

    ON MARCH 26TH, THE CUSTOMER CALLED INTO BAXA TECHNICAL SUPPORT REQUESTING ASSISTANCE SETTING UP THE COMPOUNDER AND CONCERNS REGARDING INGREDIENT SHORTAGES. DURING THE INITIAL CONTACT, IT WAS DISCOVERED THAT THERE WAS AN INCIDENT INVOLVING THREE NEONATAL PATIENTS. ON MARCH 13TH, THESE PATIENTS WERE INFUSED WITH AN INCORRECT CONCENTRATION OF K ACETATE, 4MEQ INSTEAD OF 2MEQ ENTERED INTO THE FORMULA. DURING THE SET UP OF THE DAILY TPN BAGS, THE PHARMACY TECHNICIAN HUNG A VIAL OF K ACETATE 4MEQ ONTO THE COMPOUNDER AND ENTERED K ACETATE 2MEQ INTO THE FORMULARY. WHEN TRYING TO SCAN THE K ACETATE 4MEQ INTO THE SYSTEM, THE SOFTWARE DID NOT RECOGNIZE THE BARCODE AND ALERTED THE USER. THE TECHNICIAN THEN SELECTED A DIFFERENT VIAL OF K ACETATE 2MEQ TO BE SCANNED BUT WAS NOT HUNG ON THE COMPOUNDER. THE TECHNICIAN DID NOT NOTICE THE CONCENTRATION DIFFERENCE ON THE LABELS. THE SOFTWARE CORRECTLY CALCULATED THE AMOUNT OF INGREDIENT TO BE PUMPED BASED ON THE 2MEQ INGREDIENT THAT WAS ENTERED. HOWEVER, THE 4MEQ INGREDIENT WAS PUMPED INTO THE BAGS BECAUSE, IT WAS HUNG ON THE COMPOUNDER AND INCORRECTLY SCANNED INTO THE SYSTEM. APPROXIMATELY 9 HOURS AFTER THE INCORRECT BAGS WERE INFUSED INTO THE PATIENTS, THE MISTAKE WAS NOTICED BY ANOTHER TECHNICIAN, WHO REPORTED THE EVENT TO BAXA. BAXA TECHNICAL SUPPORT INSTRUCTED THE CUSTOMER ON THE CORRECT METHOD FOR COMPOUNDER SET UP AND TO NEVER SCAN A DIFFERENT PRODUCT THAN WHAT IS BEING USED ON THE COMPOUNDER, AS STATED IN THE OPERATOR'S MANUAL. TECHNICIAN REPORTED NO ADVERSE EVENTS/PATIENT INJURY RESULTED FROM THE INFUSION OF THIS TPN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX 2400 COMPOUNDER EM2400 LHI BAXA CORP. 2400-DX

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Required Intervention