BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTAMIX 2400 COMPOUNDER

    MDR report key: 2126507 · Received May 13, 2011

    Report

    Report Number
    1419106-2011-00005
    Event Type
    Other
    Date Received
    May 13, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INITIAL CONTACT, BAXA TECHNICAL SUPPORT ASSOCIATE HAD THE CUSTOMER VERIFY THE FORMULARY WAS CORRECTLY SET UP ON THE COMPOUNDER UNDER THE CORRECT TITLE NAME. THE DEVICE OPERATED AS INTENDED, THE OPERATOR ADDED THE K ACETATE 4MEQ/ML INGREDIENT TO THE FORMULARY UNDER THE INCORRECT TITLE NAME OF K ACETATE 2MEQ/ML. THE INCORRECT TITLE NAME WAS MISSED DURING PHARMACY REVIEW. AS A RESULT, THE PTS ((B)(6)) RECEIVED DOUBLE THE AMOUNT OF THE REQUESTED POTASSIUM ACETATE. THE NEXT DAY, THE PTS WERE INFUSED WITH THE CORRECT AMOUNT. NO ADVERSE EVENTS/PATIENT INJURY RESULTED FROM THE INFUSION OF THIS TPN. A REVIEW OF RISK DOCUMENTATION WAS PERFORMED, AND IT HAS BEEN CONCLUDED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED.

    Description of Event or Problem · 1

    ON (B)(6), THE CUSTOMER CALLED INTO BAXA TECHNICAL SUPPORT STATING THEY INCORRECTLY DELIVERED A HIGHER CONCENTRATION OF K ACETATE THAT WAS DELIVERED TO TWO PTS ((B)(6)) AND INFUSED ON (B)(6) 2011. PRIOR TO COMPOUNDING THE DAILY BAGS, THE K ACETATE 4MEQ/ML INGREDIENT WAS ADDED TO THE DATABASE FORMULARY UNDER THE INCORRECT TITLE NAME K ACETATE 2MEQ/ML. ALL THE INFO ENTERED INTO THE DATABASE FORMULARY WAS CORRECT FOR THE 4MEQ INGREDIENT. THE INCORRECT TITLE NAME WAS MISSED DURING PHARMACY REVIEW. ALL TPN BAGS WERE CALCULATED USING K ACETATE 2MEQ/ML, EVEN THOUGH THE K ACETATE 4MEQ/ML INGREDIENT WAS HUNG ON THE COMPOUNDER. AS A RESULT OF THE INCORRECT TITLE NAME, BOTH PTS RECEIVED DOUBLE THE AMOUNT OF K ACETATE. THE CUSTOMER STATED 70 BAGS WERE CREATED ON (B)(6) WITH THE K ACETATE 4MEQ/ML INGREDIENT INSTEAD OF THE CALCULATED K ACETATE 2MEQ/ML INGREDIENT. THE ERROR WAS NOTICED AFTER THE BAGS LEFT THE FACILITY, ALL BAGS WERE RETURNED AND DESTROYED WITHOUT BEING INFUSED EXCEPT FOR TWO ((B)(6)).

    Additional Manufacturer Narrative · 2

    DURING INITIAL CONTACT, BAXA TECHNICAL SUPPORT ASSOCIATE HAD THE CUSTOMER VERIFY THE FORMULARY WAS CORRECTLY SET UP ON THE COMPOUNDER UNDER THE CORRECT TITLE NAME. THE DEVICE OPERATED AS INTENDED, THE OPERATOR ADDED THE K ACETATE 4MEQ/ML INGREDIENT TO THE FORMULARY UNDER THE INCORRECT TITLE NAME OF K ACETATE 2MEQ/ML. THE INCORRECT TITLE NAME WAS MISSED DURING PHARMACY REVIEW. AS A RESULT THE PTS ((B)(6)) RECEIVED DOUBLE THE AMOUNT OF THE REQUESTED POTASSIUM ACETATE. THE NEXT DAY, THE PTS WERE INFUSED WITH THE CORRECT AMOUNT. NO ADVERSE EVENTS/PATIENT INJURY RESULTED FROM THE INFUSION OF THIS TPN. A REVIEW OF RISK DOCUMENTATION WAS PERFORMED, AND IT HAS BEEN CONCLUDED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED.

    Description of Event or Problem · 2

    ON (B)(6), THE CUSTOMER CALLED INTO BAXA TECHNICAL SUPPORT STATING THEY INCORRECTLY DELIVERED A HIGHER CONCENTRATION OF K ACETATE THAT WAS DELIVERED TO TWO PTS ((B)(6)) AND INFUSED ON (B)(6) 2011. PRIOR TO COMPOUNDING THE DAILY BAGS, THE K ACETATE 4MEQ/ML INGREDIENT WAS ADDED TO THE DATABASE FORMULARY UNDER THE INCORRECT TITLE NAME K ACETATE 2MEQ/ML. ALL THE INFO ENTERED INTO THE DATABASE FORMULARY WAS CORRECT FOR THE 4MEQ INGREDIENT. THE INCORRECT TITLE NAME WAS MISSED DURING PHARMACY REVIEW. ALL TPN BAGS WERE CALCULATED USING K ACETATE 2MEQ/ML, EVEN THOUGH THE K ACETATE 4MEQ/ML INGREDIENT WAS HUNG ON THE COMPOUNDER. AS A RESULT OF THE INCORRECT TITLE NAME, BOTH PTS RECEIVED DOUBLE THE AMOUNT OF K ACETATE. THE CUSTOMER STATED 70 BAGS WERE CREATED ON (B)(6) WITH THE K ACETATE 4MEQ/ML INGREDIENT INSTEAD OF THE CALCULATED K ACETATE 2MEQ/ML INGREDIENT. THE ERROR WAS NOTICED AFTER THE BAGS LEFT THE FACILITY, ALL BAGS WERE RETURNED AND DESTROYED WITHOUT BEING INFUSED EXCEPT FOR TWO ((B)(6)).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention
    2 2 YR Required Intervention