BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400

    MDR report key: 1413810 · Received July 9, 2009

    Report

    Report Number
    1419106-2009-00016
    Event Type
    Other
    Date Received
    July 9, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 15, 2009
    Manufacturer
    BAXA CORP.
    Product Code
    NEP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AN EVAL OF THE DOCUMENTATION ASSOCIATED WITH THIS EVENT, IT WAS CONCLUDED THAT THE HIGHER-THAN-DESIRED QUANTITY OF DEXTROSE IN THE SUBJECT BAG WAS THE RESULT OF THE USER FAILING TO REMOVE THE WASTE CONTAINER AND THEN PROCEEDED TO PUMP THE SUBJECT ORDER ON TOP OF THE FLUSH VOLUMES. INVESTIGATION HAS CONFIRMED THAT THE EM2400 COMPOUNDER PERFORMED AS DESIGNED AND ALERTED THE USER THAT THE BAG WAS NOT EMPTY PRIOR TO RUNNING THE SUBJECT ORDER. CUSTOMER WAS CONTACTED AND THE RESULTS OF THE EVAL WERE DISCUSSED. TO PREVENT THIS ISSUE FROM RE-OCCURRING, THE FACILITY HAS PROVIDED ADDITIONAL TRAINING TO ALL STAFF MEMBERS WHO OPERATE THE EM2400 COMPOUNDER. IN ADDITION, THE FACILITY IS EVALUATING THEIR CURRENT PROCEDURES TO DETERMINE IF ANY CHANGES NEED TO BE MADE.

    Description of Event or Problem · 1

    ON (B)(6) 2009, BAXA WAS NOTIFIED BY THE CUSTOMER OF A PT INVOLVED INCIDENT USING THE EXACTA-MIX 2400 COMPOUNDER FOR TPN PRODUCTION. IT WAS REPORTED TO BAXA THAT THIS PT HAD RECEIVED A TPN BAG CONTAINING A HIGHER-THAN-DESIRED QUANTITY OF DEXTROSE. INFUSION WAS TERMINATED UPON DETECTING THE ERROR. THE PTS BLOOD WORK INDICATED ELEVATED GLUCOSE LEVELS. HOWEVER, NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED AND NO APPARENT LONG-TERM INJURY OR ILLNESS RESULTED FROM THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 EXACTA-MIX 2400 NEP BAXA CORP. EM 2400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Required Intervention