BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BLOOD BANK

    MDR report key: 6788722 · Received August 11, 2017

    Report

    Report Number
    3009404844-2017-00001
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Report Date
    August 8, 2017
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH)
    Product Code
    MMH
    UDI-DI
    00863529000117
    PMA / PMN Number
    BK080037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: THE MEDITECH BLOOD BANK SOFTWARE AT THE CUSTOMER LOCATION IS AVAILABLE TO MEDITECH STAFF THROUGH A SECURE VPN CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE BLOOD BANK DATABASES WITH THE SAME VERSION OF THE 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 THE BLOOD BANK SOFTWARE. EVALUATION OF MALFUNCTION: AFTER INVESTIGATING THE ISSUE REPORTED BY THE CUSTOMER FOR CLIENT SERVER RELEASE 5.66, MEDITECH PERFORMED ADDITIONAL ON-SITE AND IN-HOUSE TESTING AND DETERMINED THAT THE SAME ISSUE AFFECTS MULTIPLE RELEASES OF THE SOFTWARE. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT WHILE BLOOD BANK SPREADSHEETS USE AN ALTERED VERSION OF THE SPECIMEN IDENTIFIER TO GROUP MULTIPLE CROSSMATCHES FOR ONE SPECIMEN, THE ORIGINATING ISSUE CHANGED THIS VALUE TO ALLOW SCREEN HEADERS TO WORK CONSISTENTLY, WHICH IN TURN PREVENTED THE CROSSMATCH TESTS FROM BEING TRACKED ACCURATELY. IF THE ISSUE WERE TO RECUR IN A CUSTOMER'S LIVE ENVIRONMENT, AND THE RESULT OF A CROSS-MATCHABLE RED BLOOD CELL PRODUCT COMPONENT TEST IS CHANGED BY THE SYSTEM, THIS CHANGE COULD TRIGGER THE COMPATIBILITY CALCULATION AND MAY CHANGE THE CROSSMATCH COMPATIBILITY RESULT WITHOUT ANY INDICATION TO THE END USER. IF THE ORIGINAL CROSSMATCH COMPATIBLE RESULT WAS CALCULATED WITH A RESULT OF NO AND IT IS THEN CHANGED TO YES WITHOUT A WARNING TO THE USER, THERE MAY BE A POTENTIAL FOR A PATIENT TO RECEIVE AN INCOMPATIBLE UNIT OF BLOOD. FACTORS IN MITIGATING RISK: THE RISK TO HEALTH IS LOW AS THE CHANGED CROSSMATCH COMPONENT RESULT IS VISIBLE TO THE END USER IN BOTH THE COMMENT BOX HEADER AND THE SPREADSHEET RESULT ENTRY SCREEN. IN ADDITION, BLOOD ESTABLISHMENTS TYPICALLY RE-TYPE UNITS AS THEY COME INTO INVENTORY, AS WELL AS, PERFORM PHYSICAL CHECKS ON THE BLOOD COMPATIBILITY SUCH AS IDENTIFYING INCOMPATIBILITY OF UNIT WHEN THE BLOOD CLOTS IN THE TEST TUBE, PRIOR TO THE SOFTWARE ISSUE OCCURRING. HOWEVER, IF THIS ISSUE WERE TO GO UNNOTICED AND A PATIENT RECEIVED A UNIT OF INCOMPATIBLE RED BLOOD CELLS, THE RESULT OF THIS MEDICAL ERROR COULD POTENTIALLY LEAD TO A TRANSFUSION REACTION. THE PRELIMINARY RISK ANALYSIS CONDUCTED INDICATED THE LIKELIHOOD OF THE ISSUE OCCURRING WAS MEDIUM. HOWEVER, FURTHER RESEARCH AND ANALYSIS DETERMINED THAT THE LIKELIHOOD OF THE ISSUE ACTUALLY REACHING THE PATIENT IS LOW DUE TO THE ITEMS NOTED BELOW. THE PATIENT WOULD NEED TO HAVE MORE THAN 1 RED BLOOD CELL PRODUCT ORDER, AND THEIR CROSSMATCH WOULD HAVE TO BE RESULTED ON A BLOOD BANK SPREADSHEET WHERE THE COMMENT BUTTON WAS ALSO ACCESSED. THE LIKELIHOOD OF THIS ISSUE GOING UNDETECTED IS LOW FOR THE FOLLOWING REASONS: WHEN THE CROSSMATCH COMPONENT TEST RESULTS ARE THE SAME, THE RESULTS WOULD CHANGE TO THE SAME VALUE AND THE COMPATIBLE PROMPT WOULD NOT BE ALTERED. WHEN THE CROSSMATCH COMPONENT RESULTS ARE VERIFIED AND THE END USER ACCESSES THE SPREADSHEET TO ENTER A COMMENT, THE SYSTEM DISPLAYS A WARNING MESSAGE TO THE USER INDICATING THAT A VERIFIED RESULT IS BEING CHANGED. TO MINIMIZE THE RISK OF POTENTIAL PATIENT HARM, THE RECOMMENDED WORKAROUND PROVIDES AN IMMEDIATE AND STRONG MITIGATION FOR THIS PROBLEM UNTIL THE IDENTIFIED CUSTOMER SYSTEMS WITH THIS MALFUNCTION RECEIVE THE SOFTWARE CORRECTION. RECOMMENDED WORKAROUND: USERS ARE INSTRUCTED TO USE THE MANUAL RESULT ENTRY ROUTINE RATHER THAN THE SPREADSHEET RESULT ENTRY ROUTINE. RESULT COMMENTS CAN BE VIEWED WHILE IN THE BLOOD BANK SPREADSHEET RESULTS USING THE VIEW FOOTER BUTTON, RATHER THAN THE COMMENT FOOTER BUTTON. THIS ISSUE AFFECTS MEDITECH BLOOD BANK SOFTWARE RELEASES 5.65, 5.66, 5.67, 6.07, 6.08, 6.14, 6.15 AND 6.16. SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR ALL RELEASES NOTED ABOVE SO THAT WHEN COMMENTS ARE VIEWED FOR CROSSMATCH TESTS IN THE BLOOD BANK ENTER/EDIT SPREADSHEET RESULTS ROUTINE, THE RESULT OF THE TEST IS NOT CHANGED. MEDITECH HAS EVALUATED THE DEVICE AFTER THE CORRECTION WAS MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. THE ACTUAL SOFTWARE CORRECTION IS BEING TRACKED UNDER (B)(4). NOTIFICATION AND DISTRIBUTION: BEGINNING ON JULY 31, 2017, MEDITECH DISTRIBUTED A NOTIFICATION TO CUSTOMERS WHO HAVE THE MEDITECH BLOOD BANK SOFTWARE PRODUCT IN EITHER THEIR TEST OR LIVE ENVIRONMENT FOR THE RELEASES NOTED ABOVE. THIS NOTIFICATION WAS MADE VIA E-MAILED TASK 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 IDENTIFIED CUSTOMERS BEGINNING ON AUGUST 4, 2017.

    Description of Event or Problem · 1

    ON JULY 18, 2017, A MEDITECH CUSTOMER REPORTED THAT IN THEIR LIVE BLOOD BANK SOFTWARE ENVIRONMENT, AN UNVERIFIED TEST RESULT HAD BEEN CHANGED BY THE SYSTEM TO A DIFFERENT RESULT. A USER WAS ENTERING CROSSMATCH RESULTS FOR A RED BLOOD CELL PRODUCT VIA THE BLOOD BANK ENTER/EDIT SPREADSHEET RESULTS ROUTINE. WHEN THE USER VIEWED A COMMENT ASSOCIATED TO ONE OF THE CROSSMATCH COMPONENT TESTS, THE RESULT OF THAT COMPONENT TEST WAS CHANGED. THE CUSTOMER NOTICED THE RESULT CHANGING ON THE SCREEN AS THE PROBLEM WAS OCCURRING AND WAS ABLE TO RESOLVE THE ISSUE THROUGH OTHER MEANS. THE CUSTOMER REPORTED TO MEDITECH THAT THEY WERE ABLE TO REPRODUCE THE ISSUE IN THEIR TEST BLOOD BANK SOFTWARE ENVIRONMENT. MEDITECH INVESTIGATED THE REPORTED MALFUNCTION AND ON JULY 21, 2017, WAS ABLE TO REPRODUCE THE ISSUE IN MEDITECH'S IN-HOUSE, CONTROLLED TESTING ENVIRONMENT. IN ORDER FOR THIS ISSUE TO OCCUR, THE PATIENT MUST HAVE MORE THAN 1 CROSSMATCHABLE RED BLOOD CELL PRODUCTS ON ORDER, AND HAVE THEIR CROSSMATCH COMPONENT TESTS RESULTED VIA A BLOOD BANK SPREADSHEET WHERE THE "COMMENTS" FOOTER BUTTON IS ACCESSED. THIS DECREASES THE LIKELIHOOD OF THIS ISSUE OCCURRING. IF THE RESULT OF A CROSS-MATCHABLE RED BLOOD CELL PRODUCT COMPONENT TEST IS CHANGED BY THE SYSTEM, THIS CHANGE COULD TRIGGER THE COMPATIBILITY CALCULATION AND MAY CHANGE THE CROSSMATCH COMPATIBILITY RESULT WITHOUT ANY INDICATION TO THE END USER. IF THE ORIGINAL CROSSMATCH COMPATIBLE RESULT WAS CALCULATED WITH A RESULT OF NO AND IT IS THEN CHANGED TO YES WITHOUT A WARNING TO THE USER, THERE MAY BE A POTENTIAL FOR A PATIENT TO RECEIVE AN INCOMPATIBLE UNIT OF BLOOD. THE ISSUE HAS BEEN CORRECTED. WHEN COMMENTS ARE VIEWED FOR CROSSMATCH TESTS ON RED BLOOD CELL PRODUCTS IN THE BLOOD BANK ENTER/EDIT SPREADSHEET RESULTS ROUTINE, THE RESULT OF THE TEST IS NOT CHANGED. BEGINNING ON JULY 31, 2017, MEDITECH DISTRIBUTED A NOTIFICATION TO ALL IMPACTED CUSTOMERS VIA AN AUTOMATED E-MAIL FROM OUR TASK SYSTEM (CUSTOMER SERVICE COMPLAINT HANDLING TOOL). BEGINNING ON AUGUST 4, 2017, THE CORRECTION IS BEING DELIVERED TO ALL IDENTIFIED CUSTOMERS. ALTERNATE WORKFLOW INSTRUCTIONS ARE PROVIDED TO CUSTOMERS IN AN EFFORT TO MITIGATE RISK PRIOR TO THE CORRECTION BEING ACCEPTED. TO MINIMIZE THE RISK OF POTENTIAL PATIENT HARM, THE RECOMMENDED WORKAROUND PROVIDES AN IMMEDIATE AND STRONG MITIGATION FOR THIS PROBLEM UNTIL THE IDENTIFIED CUSTOMER SYSTEMS WITH THIS MALFUNCTION RECEIVE THE SOFTWARE CORRECTION. RECOMMENDED WORKAROUND: USERS ARE INSTRUCTED TO USE THE MANUAL RESULT ENTRY ROUTINE RATHER THAN THE SPREADSHEET RESULT ENTRY ROUTINE. RESULT COMMENTS CAN BE VIEWED WHILE IN THE BLOOD BANK SPREADSHEET RESULTS USING THE VIEW FOOTER BUTTON, RATHER THAN THE COMMENT FOOTER BUTTON. AN FDA RECALL/CORRECTION REPORT IS BEING INITIATED FOR THIS ISSUE, THE CORRECTION REPORT NUMBER IS 3009404844-07/31/17-001-C. THIS HAS BEEN SUBMITTED TO THE FDA NEW ENGLAND DISTRICT OFFICE. NO PATIENT HARM HAS BEEN REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569802 MEDITECH BLOOD BANK MEDITECH BLOOD BANK SOFTWARE MMH MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH) RELEASES 5.65, 5.66. 5.67, 6.07, 6.08, 6.14, 6.15 AND 6.16 00863529000117

    Patients

    Seq Age Sex Outcome Treatment
    1