BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXACTA-MIX 2400 SOFTWARE

    MDR report key: 914509 · Received September 14, 2007

    Report

    Report Number
    1419106-2007-00010
    Event Type
    Other
    Date Received
    September 14, 2007
    Date of Event
    August 19, 2007
    Report Date
    August 20, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS FACILITY, CIMETADINE IS ALWAYS ADDED MANUALLY AFTER THE COMPOUNDER CREATES THE BAG. PRIOR TO CONTACTING BAXA'S TECHNICAL SUPPORT, THE CUSTOMER DETERMINED THAT THE CONCENTRATION OF CIMETADINE WAS INADVERTENTLY CHANGED IN THE FORMULARY TO A DILUTION OF 10MG/ML. WHEN THE SOFTWARE CALCULATED THE COMPOUND, IT WAS USING THE DILUTION OF 10MG/ML AND REPORTED THE CORRECT VALUE. HOWEVER, UPON PRINTING OUT THE MIXCHECK REPORT, INCLUDING THE MANUAL ADDS, IT SAID "CIMETADINE DILU." WHEN THE TECH READ THIS THEY DID NOT USE THE DILUTED INGREDIENT BUT THE CONCENTRATED AMOUNT FOR THE DILUTION. A REVIEW OF THE PRODUCT HAZARD ANALYSIS (PHA) AND CUSTOMER COMPLAINT DATA FOR ABACUS WAS CONDUCTED AND IT WAS DETERMINED THAT THIS ISSUE NOT OCCURING WITH GREATER FREQUENCY OR SEVERITY THAN IS EXPECTED FOR THE DEVICE, AS DOCUMENTED IN THE PHA.

    Description of Event or Problem · 1

    IN 2007, BAXA WAS NOTIFIED OF AN INCIDENT WHICH RESULTED IN A PT BECOMING "IRRITABLE" DURING TREATMENT; NO MEDICAL INTERVENTION, LAB TESTS, CX ADD'L MONITORING WAS REQUIRED. THE CUSTOMER REPORTED THAT WHILE USING THE EXACTA-MIX 2400 SOFTWARE TO CREATE A TPN SOLUTION, THE INCORRECT CONCENTRATION AND AMOUNT OF CIMETADINE WAS ENTERED RESULTING IN A 15X OVER-DELIVERY. THE MIXCHECK REPORT WAS SET FOR CIMETADINE DILUTION 10MG/ML, HOWEVER, CIMETADINE 150MG/ML WAS MANUALLY ADDED TO THE COMPOUND, AND DELIVERED. THE REPORTED INCIDENT WAS NOT FOUND UNTIL THE FOLLOWING DAY DURING COMPOUNDING. ONCE THE ERROR WAS FOUND, THE PT'S NURSE WAS CONTACTED FOR PT INFORMATION. THE ATTENDING NURSE STATED THAT DURING THE INFUSION THE PT EXPERIENCED "INCREASED IRRITABILITY" HOWEVER, THE INFUSION WAS NOT STOPPED NOR WAS ANY ADD'L MONITORING OR MEDICAL INTERVENTION PERFORMED. THE PT HAS BEEN REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 2400 SOFTWARE EXACTA-MIX 2400 SOFTWARE LHI BAXA CORPORATION 8300-0014 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other