BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABACUS SOFTWARE

    MDR report key: 5094350 · Received September 22, 2015

    Report

    Report Number
    1419106-2015-00227
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Report Date
    September 22, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS UNKNOWN. NO PRODUCT WAS RETURNED AND BECAUSE A SERIAL NUMBER WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. HOWEVER THE CUSTOMER PROVIDED THE PHYSICIAN ORDER FORM AND THIS PROVIDED DETAILS ABOUT THE ORDER AND WHAT WAS COMPOUNDED. BASED ON THE CUSTOMER REPORT AND THE REVIEW OF THE PHYSICIAN ORDERS, THIS EVENT WAS DETERMINED TO BE RELATED TO USER ERROR. THE ABACUS USER GUIDE DIRECTS THE USER TO THAT THE FORMULARY MUST BE CORRECT AND UP TO DATE SO THAT THE ABACUS SOFTWARE CAN PROVIDE THE BEST INFORMATION FOR PATIENT SAFETY. CONTACT TECHNICAL SUPPORT BEFORE MAKING CHANGES TO THE FORMULARY. DO NOT MAKE CHANGES WITHOUT WORKING CLOSELY WITH TECHNICAL SUPPORT. THE ABACUS USER GUIDE DIRECTS USERS TO THOROUGHLY REVIEW ALL ORDER DATA BECAUSE SERIOUS HARM OR DEATH MAY OCCUR IF AN ADEQUATE REVIEW ISN'T COMPLETED. THE ABACUS SOFTWARE CHANGES AN ORDER TO COMPLETE ONLY AFTER AN AUTHORIZED USER COMPLETELY FINISHES AND APPROVES AN ORDER. A THOROUGH REVIEW OF ALL DATA ON EACH TAB IN THE ORDER ENTRY PROCESS WILL MINIMIZE THE RISK OF MEDICATION ERROR. THIS IS REPORT 1 OF 4. THIS EVENT IS LOGGED UNDER COMPLAINT FILE #(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER TECHNICAL SUPPORT THAT THE MULTITRACE 4 PEDS WAS DOUBLING. THROUGH TROUBLESHOOTING, IT WAS DETERMINED THAT FOR THE INGREDIENT TYPE, BASE WAS SELECTED INSTEAD OF OTHER FOR THE MULTITRACE 4 PEDS INGREDIENT. THE INCORRECT INGREDIENT TYPE SELECTION IS WHAT CAUSED THE DOUBLING OF MULTITRCE 4 PEDS. BAXTER TECHNICAL SUPPORT INSTRUCTED THE PHARMACIST TO GO BACK INTO THE FORMULARY AND SELECT OTHER FOR THE INGREDIENT TYPE. WHEN THE FORMULARY TYPE WAS CHANGED TO OTHER, THE ORDER WAS CORRECT AND RESOLVED THE ISSUE OF THE MULTITRACE 4 PEDS INGREDIENT FROM DOUBLING. WHEN THE FORMULARY CHANGE WAS INITIALLY DONE, THE CUSTOMER DID NOT CALL BAXTER CUSTOMER SUPPORT FOR ASSISTANCE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. NO ADVERSE EVENT WAS REPORTED. THE CURRENT STATUS OF THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627076 ABACUS SOFTWARE ABACUS SOFTWARE JQP BAXTER HEALTHCARE CORPORATION 8300-0169 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TPN