BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH CLIENT SERVER BLOOD BANK SOFTWARE

    MDR report key: 2868095 · Received August 3, 2012

    Report

    Report Number
    3009404844-2012-00002
    Event Type
    Malfunction
    Date Received
    August 3, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 23, 2012
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY INC.
    Product Code
    MMH
    PMA / PMN Number
    BK080037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: SOFTWARE MALFUNCTION CONTRIBUTED TO PRODUCT PROBLEM. DEVICE AVAILABLE FOR EVALUATION: THE CLIENT SERVER BLOOD BANK SOFTWARE AND DATABASE AT THE CUSTOMER LOCATION IS AVAILABLE TO (B)(6) STAFF THROUGH A SECURE VPN CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE DATABASES WITH THE SAME VERSION OF SOFTWARE: A TEST DATABASE USED FOR RESEARCH, TESTING, AND VERIFICATION; AND A LIVE DATABASE USED FOR RECORDING THE DAILY OPERATIONS OF THE HOSPITAL'S BLOOD BANK DEPARTMENT. MEDITECH MAINTAINS CONTROLLED TESTING ENVIRONMENTS FOR THE CUSTOMER VERSION AS WELL AS FOR ALL VERSIONS OF BLOOD BANK STANDARD SOFTWARE. EVALUATION OF MALFUNCTION: AFTER INVESTIGATING THE ISSUE REPORTED BY THE CUSTOMER FOR CLIENT SERVER RELEASE 6.06, MEDITECH PERFORMED ADDITIONAL ON-SITE AND INHOUSE TESTING AND DETERMINED THAT THE SAME ISSUE AFFECTS MULTIPLE RELEASES OF CLIENT SERVER. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT THE MALFUNCTION COULD INVOLVE SOME BLOOD BANK UNITS BEING FILED INTO THE SYSTEM WITH MISMATCHING BLOOD TYPES. THE ERROR ONLY OCCURS WHEN THE USER FIRST ACCESSES THE "ENTER UNITS W/RESULT ENTRY" ROUTINE AND THEN UTILIZES THE "ENTER UNITS BY BATCH" ROUTINE. UPON FILING THE "ENTER UNIT BY BATCH" ROUTINE, THE SYSTEM WILL AUTOMATICALLY BRANCH THE USER INTO THE "ENTER/EDIT BBK RESULTS" ROUTINE. WHILE IN THE "ENTER/EDIT BBK RESULTS" ROUTINE, TWO SITUATIONS CAN OCCUR: IF THE USER ENTERS A BLOOD TYPE THAT DOES NOT MATCH THE USER-DEFINED BLOOD TYPE CALCULATION RESULT, THE STANDARD WARNING MESSAGE INDICATING THE MISMATCHED BLOOD TYPES DOES NOT DISPLAY AND THE USER CAN FILE THE MISMATCHED BLOOD TYPE. THE USER CAN FILE A BLOOD TYPE ON THE BLOOD BANK UNIT THAT DOES NOT MATCH THE SOURCE BLOOD TYPE AND WILL NOT RECEIVE STANDARD WARNING MESSAGES ABOUT THE MISMATCH. THE USER CAN THE FILE THE MISMATCHED BLOOD TYPE WHEN THEY NORMALLY WOULD NOT HAVE ACCESS TO OVERRIDE THE WARNING MESSAGE THAT SHOULD BE DISPLAYING. THIS ISSUE AFFECTS CLIENT SERVER BLOOD BANK RELEASES (B)(6). SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR ALL OF THE CLIENT SERVER RELEASES NOTED ABOVE TO ENSURE THAT UPON FILING THE "ENTER UNITS BY BATCH" ROUTINE IN THE BLOOD BANK SYSTEM, THE USER WILL NOT BE AUTOMATICALLY BRANCHED INTO THE "ENTER/EDIT BK RESULTS" ROUTINE. THE USER MUST ACCESS THE "ENTER/EDIT BBK RESULTS" ROUTINE DIRECTLY AND NONE OF THE ISSUES NOTED WILL OCCUR AT THAT TIME. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. THE FOLLOWING WORKAROUND HAS ALSO BEEN PROVIDED: IF THE USER IS BRANCHED INCORRECTLY FROM THE 'ENTER UNITS BY BATCH" ROUTINE INTO THE "ENTER/EDIT BBK RESULTS" ROUTINE, THE USER WILL BE INSTRUCTED TO IMMEDIATELY EXIT FROM THE "ENTER/EDIT BK RESULTS" ROUTINE WITHOUT ENTERING ANY RESULTS. NOTIFICATION AND DISTRIBUTION: BEGINNING ON (B)(4) 2012 MEDITECH DISTRIBUTED A NOTIFICATION TO CUSTOMERS WHO ARE LIVE WITH MEDITECH CLIENT SERVER BLOOD BANK RELEASE (B)(6) AND HIGHER. THIS NOTIFICATION WAS MADE VIA E-MAILED TAKES UPDATES THAT CAN BE PRINTED BY THE CUSTOMER. TASK UPDATES SENT VIA E-MAIL ARE IMMEDIATELY TRANSMITTED TO THE CUSTOMER. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED BEGINNING ON (B)(4) 2012.

    Description of Event or Problem · 1

    DESCRIPTION OF THE PROBLEM: ON (B)(6) 2012, WHILE PERFORMING SOFTWARE TESTING IN THEIR CLIENT (B)(6), A MEDITECH CUSTOMER REPORTED THAT UNDER CERTAIN CIRCUMSTANCES, THEY WERE NOT RECEIVING STANDARD WARNING MESSAGES ABOUT CONFLICTING BLOOD BANK UNIT BLOOD TYPES. THEY ALSO INDICATED THAT UNDER THESE CIRCUMSTANCES THE BLOOD TYPE CALCULATION THEY HAD SET UP WAS NOT INVOKING CORRECTLY WHEN TRYING TO RE-TYPE A BLOOD BANK UNIT. MEDITECH INVESTIGATED THE PROBLEM, AND ON (B)(6) 2012, CONFIRMED THAT THE ISSUES NOTED ABOVE CAN OCCUR UNDER THE FOLLOWING CONDITIONS: IFA BLOOD BANK USER ACCESSES THE "ENTER UNITS W/RESULT ENTRY" ROUTINE AND THEN UTILIZES THE "ENTER UNITS BY BATCH" ROUTINE, THE SYSTEM WILL AUTOMATICALLY BRANCH THE USER INTO THE "ENTER/EDIT BBK RESULTS" ROUTINE AFTER THE "ENTER UNIT BY BATCH" ROUTINE IS FILED. WHILE THE USER IS IN THE "ENTER/EDIT BBK RESULTS" ROUTINE, THERE ARE TWO SCENARIOS OF CONCERN: WHEN RE-TYPING A BLOOD BANK UNIT, IF A USER ENTERS A BLOOD TYPE FOR THE BLOOD BANK UNIT SPECIMEN THAT DOES NOT MATCH THE CALCULATION THEY HAVE DEFINED FOR THAT BLOOD TYPE, THE WARNING MESSAGE THAT THE ENTERED RESULT DOES NOT MATCH THE CALCULATED RESULT IS NOT RECEIVED. USERS ARE ABLE TO FILE THE BLOOD BANK UNIT RE-TYPE EVEN THOUGH IT DOES NOT MATCH THE CALCULATED RESULT AND THEY DO NOT HAVE ACCESS TO OVERRIDE THIS MISMATCH. WHEN RE-TYPING A BLOOD BANK UNIT, IF A USER ENTERS A BLOOD TYPE FOR THE BLOOD BANK UNIT SPECIMEN THAT DOES NOT MATCH THE UNIT'S SOURCE BLOOD TYPE, USERS ARE NOT RECEIVING THE WARNING MESSAGE THAT THE BLOOD TYPE ENTERED DOES NOT MATCH THE UNIT'S SOURCE BLOOD TYPE. AS NO MESSAGE IS RECEIVED, USERS DO NOT NEED TO ENTER A REASON FOR THE OVERRIDE. THEREFORE, THE AUDIT TRAIL FOR THIS OVERRIDE IS NOT COMPLETE, AND USERS ARE ABLE TO FILE MISMATCHED BLOOD TYPES WITHOUT HAVING TO ENTER A REASON TO CONFIRM THIS ENTRY. SHOULD EITHER OF THE ABOVE SITUATIONS OCCUR THE VISUAL INSPECTION UPON PERFORMING A CROSSMATCH BETWEEN THE UNIT OF BLOOD AND THE PATIENT SHOULD CATCH THE DISCREPANCY. ALTHOUGH UNLIKELY, IF EITHER SITUATION WERE TO OCCUR A LIVE ENVIRONMENT, IT MAY BE POSSIBLE FOR AN UNSUITABLE BLOOD BANK UNIT TO BE TRANSFUSED TO A PATIENT AND POTENTIALLY CAUSE A TRANSFUSION REACTION OR PATIENT HARM. A WORKAROUND IS AVAILABLE: IF THE USER IS BRANCHED INCORRECTLY FROM THE "ENTER UNITS BY BATCH" ROUTINE INTO THE "ENTER/EDIT BBK RESULTS" ROUTINE, THE USER WILL BE INSTRUCTED TO IMMEDIATELY EXIT FROM THE "ENTER/EDIT BBK RESULTS" ROUTINE WITHOUT ENTERING ANY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH CLIENT SERVER BLOOD BANK SOFTWARE MEDITECH BLOOD BANK, PRODUCT CODE: MMH MMH MEDICAL INFORMATION TECHNOLOGY INC. RELEASES 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1, 6.12

    Patients

    Seq Age Sex Outcome Treatment
    1