BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTAMIX® 2400 COMPOUNDER

    MDR report key: 2504353 · Received March 26, 2012

    Report

    Report Number
    1419106-2012-00003
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    December 1, 2011
    Report Date
    February 27, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPOUNDER WILL NOT BE EVALUATED AS THERE IS NO FUNCTIONAL DEFICIENCIES REPORTED. METHOD: THE EM2400 COMPOUNDER MANUAL WAS REVIEWED AND SOME IMPROVEMENTS TO THE MANUAL WERE FOUND. RESULTS: AFTER REVIEWING THE EM2400 COMPOUNDER MANUAL, IT WAS FOUND THAT THE INSTRUCTIONS CAN BE IMPROVED TO BETTER REFLECT CLEANING THE COMPOUNDER. CONCLUSION: THE MANUAL COULD BE MORE CLEAR WITH RESPECT TO MOVING THE COMPOUNDER FOR CLEANING AND WILL BE UPDATED WITH MORE SPECIFIC INSTRUCTIONS THE OPERATORS WERE MOVING THE COMPOUNDER INCORRECTLY AND WERE BRUISING THEIR ARMS. ADDITIONAL TRAINING HAS BEEN PROVIDED BY BAXA TECHNICAL SUPPORT AND THE DIRECTOR OF PRODUCT INTEGRATION. AFTER REVIEWING THE OPERATOR MANUAL FOR THE EM2400 COMPOUNDER, IT WAS CONCLUDED THAT THE MANUAL COULD BE MORE CLEAR WITH RESPECT TO MOVING THE COMPOUNDER FOR CLEANING AND WILL BE UPDATED WITH MORE SPECIFIC INSTRUCTIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2012, BAXA TECHNICAL SUPPORT WAS CONTACTED IN REGARDS TO AN OPERATOR-INVOLVED INCIDENT. THE CUSTOMER REPORTED SEVERAL OPERATORS WERE BRUISING THEIR FOREARMS AS A RESULT OF MOVING THE EXACTAMIX 2400 COMPOUNDER TO CLEAN IT. THE EXACT NUMBER OF OPERATORS INVOLVED IS UNKNOWN; HOWEVER, ALL OPERATORS INVOLVED ARE FEMALE AND RANGE FROM (B)(6). THE DATE OF THE EVENT WAS REPORTED AS, "SOME TIME IN THE LAST 2 MONTHS AT VARIOUS TIMES." THE CUSTOMER ALSO REPORTS, "THERE IS ALWAYS ONLY ONE OPERATOR MOVING THE COMPOUNDER WHEN CLEANING IT ONCE A DAY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other