BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BLOOD BANK SOFTWARE

    MDR report key: 2370263 · Received May 19, 2011

    Report

    Report Number
    1222805-2011-00003
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 22, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK080037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: CONTROLLED TESTING ENVIRONMENTS OF THE BLOOD BANK SOFTWARE OF THE SAME VERSION AS CUSTOMER SITES ARE MAINTAINED IN-HOUSE BY MEDITECH FOR CUSTOMER MAINTENANCE OF THE STANDARD PRODUCT. MEDITECH ALSO MAINTAINS CONTROLLED, NON-RELEASED TESTING ENVIRONMENTS FOR ALL VERSIONS OF OUR STANDARD SOFTWARE. EVALUATION OF THE MALFUNCTION: ONE OF THE QUALIFICATIONS OF ELECTRONIC CROSSMATCH IS THAT THE SYSTEM REQUIRES TWO SOURCES OF VERIFIED BLOOD TYPE ON A PATIENT TO BE ON FILE. INVESTIGATION OF THE SOFTWARE IN MEDITECH'S IN-HOUSE CONTROLLED TESTING ENVIRONMENT CONFIRMED THAT ELECTRONIC CROSSMATCH CAN INVOKE AND PASS IN THE SITUATION DESCRIBED WHEN ONLY ONE VERIFIED BLOOD TYPE IS SAVED ON THE PATIENT'S BLOOD BANK HISTORY. THE CROSSMATCH LOGIC FAILED TO RECOGNIZE THE CHANGE IN BLOOD TYPE BY THE SECOND USER ON THE SAME SPECIMEN. SOFTWARE CORRECTION: MEDITECH HAS MODIFIED THE SOFTWARE FOR MAGIC RELEASE 5.6 TO INCREASE THE EFFECTIVENESS OF THE ELECTRONIC CROSSMATCH LOGIC TO DETECT SITUATIONS WHERE MORE THAN ONE USER IS ACCESSING THE FILES USED IN MAKING A DETERMINATION OF COMPATIBILITY. ADDITIONAL CHECKS AND A WARNING MESSAGE HAVE BEEN ADDED. THIS INCLUDES CHECKING FOR QUALIFYING UNIT BLOOD TYPE, CLINICALLY SIGNIFICANT ANTIBODIES, TWO REQUIRED VERIFIED BLOOD TYPES, AND PENDING RESULTS FOR ANTIBODY SCREENS, ANTIBODY TESTS, AND BLOOD TYPE RESULTS. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. NOTIFICATION AND DISTRIBUTION: MEDITECH HAS NOTIFIED ALL BLOOD BANK CUSTOMERS USING ELECTRONIC CROSSMATCH. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS USING ELECTRONIC CROSSMATCH

    Description of Event or Problem · 1

    ON (B)(6) 2011, A MEDITECH STAFF MEMBER REPORTED THAT, DURING IN-HOUSE SOFTWARE TESTING, THE SYSTEM ALLOWED AN ELECTRONIC CROSSMATCH IN A SITUATION WHERE IT SHOULD BE PREVENTED. UNDER TEST CONDITIONS, THE SYSTEM INVOKED AND FILED AN ELECTRONIC CROSSMATCH AS COMPATIBLE WITHOUT TWO VERIFIED BLOOD TYPE RESULTS IN A SOFTWARE TESTING ENVIRONMENT. OUR INITIAL INVESTIGATION FOUND THAT THIS CAN ONLY OCCUR UNDER THE FOLLOWING CONDITIONS: ELECTRONIC CROSSMATCH MUST BE TURNED ON FOR THE LAB SITE BEING USED; AND A PATIENT MUST HAVE ONE VERIFIED BLOOD TYPE STORED ON THEIR BLOOD BANK HISTORY AND CAN ONLY OCCUR AFTER EDITING A SECOND VERIFIED BLOOD TYPE RESULT FOR THE PATIENT WHILE THE CROSSMATCH TEST IS BEING PROCESSED. A USER ORDERS A SECOND BLOOD TYPE TEST EITHER ON THE SAME SPECIMEN OR ON A NEW SPECIMEN. THE USER ALSO ORDERS A UNIT OF A CROSSMATCHABLE PRODUCT AND A TYPE AND SCREEN ON THE SPECIMEN. THE SECOND BLOOD TYPE TEST IS RESULTED AS THE SAME BLOOD TYPE ON THE PATIENT'S HISTORY AND IS FILED AND VERIFIED. THE ANTIBODY SCREEN IS RESULTED AS NEGATIVE AND FILED AND VERIFIED. A UNIT OF PACKED CELLS OF THE SAME BLOOD TYPE AS THE PATIENT IS MADE AVAILABLE FOR CROSSMATCH. USING TWO SEPARATE USERS: USER 1 ACCESSES THE PATIENT'S SPECIMEN IN THE BLOOD BANK ENTER/EDIT RESULTS ROUTINE IN ORDER TO CROSSMATCH A UNIT. IN A SEPARATE SESSION, USER 2 ACCESSES THE SAME SPECIMEN FOR THE PATIENT IN THE BLOOD BANK ENTER/EDIT RESULTS ROUTINE IN ORDER TO CHANGE THE BLOOD TYPE RESULTS. USER 2 EDITS THE BLOOD TYPE RESULT IN THE SPECIMEN TO A DIFFERENT BLOOD TYPE. A WARNING MESSAGE APPEARS TO USER 2 INDICATING THAT THE NEW BLOOD TYPE DOES NOT MATCH THE PATIENT'S BLOOD TYPE. USER 2 ACKNOWLEDGES THE MESSAGE AND CONTINUES. ANOTHER WARNING MESSAGE APPEARS UPON FILING INDICATING THAT THE NEW BLOOD TYPE CANNOT BE VERIFIED BECAUSE IT DOES NOT MATCH THE PATIENT'S BLOOD BANK HISTORY FILE. THE RESULTS ARE FILED AS PENDING, AND THE HISTORY IS NOT UPDATED WITH THE MODIFIED RESULTS. USER 2 EXITS THE MESSAGE. USER 1 NOW ENTERS THE UNIT OF PACKED CELLS INTO THE CROSSMATCH RESULT FIELD ON THE BLOOD BANK SPECIMEN. ELECTRONIC CROSSMATCH IS INVOKED AND THE UNIT OF PACKED CELLS GOES INTO A COMPATIBLE STATUS. THE SYSTEM FAILS TO RE-CHECK THAT THERE ARE TWO SOURCES OF A VERIFIED BLOOD TYPE FOR THE PATIENT ON FILE, WHICH WOULD PREVENT ELECTRONIC CROSSMATCH FROM INVOKING AND PASSING. OUR ANALYSIS CONCLUDED THAT IN A LIVE ENVIRONMENT, THIS SOFTWARE FAILURE COULD LEAD TO AN UNSUITABLE UNIT BEING CROSSMATCHED AND TRANSFUSED TO A PATIENT, POSSIBLY RESULTING IN TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BLOOD BANK SOFTWARE MEDITECH BLOOD BANK, PRODUCT CODE: MMH MMH MEDICAL INFORMATION TECHNOLOGY, INC. CS 5.6, 6.0, 6.1

    Patients

    Seq Age Sex Outcome Treatment
    1