BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANSE BLOOD BANK

    MDR report key: 21784724 · Received April 7, 2025

    Report

    Report Number
    3009404844-2025-00003
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Report Date
    April 7, 2025
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK180219
    Removal / Correction Number
    3009404844-04/07/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 10, 2025, A MEDICAL INFORMATION TECHNOLOGY, INC. CUSTOMER REPORTED THAT USERS WERE ENCOUNTERING ERRORS WHEN SCANNING UNIT LABEL BARCODES IN THE EXPANSE BLOOD BANK PRODUCT. ONE USER DESCRIBED SCANNING RED BLOOD CELL UNITS INTO INVENTORY WHERE MIS-SCANS RESULTED IN THE UNITS BEING INITIALLY ENTERED WITH THE WRONG BLOOD TYPE. THE USER CAUGHT THE BLOOD TYPE ERROR ON THE UNIT WHEN ENTERING THE UNIT BLOOD GROUPING. THEY THEN DELETED THE SAMPLES AND THE UNITS FROM THE SYSTEM. AT THAT POINT THE USER REPEATED THE UNIT LABEL BARCODE SCANNING PROCESS AND SUCCESSFULLY SCANNED THE UNIT'S BLOOD TYPE INTO THE SYSTEM. ON MARCH 13, 2025, MEDICAL INFORMATION TECHNOLOGY, INC. IDENTIFIED A PREVIOUSLY CODED SOFTWARE CORRECTION WHICH WOULD CORRECT THE BLOOD BANK SCANNING ISSUE THE CUSTOMER WAS EXPERIENCING. THE ISSUE WAS CONFIRMED TO BE RELATED TO A TECHNICAL CHANGE THAT WAS IMPLEMENTED IN OUR WEB PRESENTATION LAYER (WPL) WEB CLIENT WHICH CHANGED HOW THE SYSTEM READS INPUTS. THE SOFTWARE CORRECTION WAS IDENTIFIED AND FURTHER EXPANSIVE TESTING CONTINUED DUE TO THE BROAD IMPACT OF THIS ISSUE. AN INTERNAL PRIORITY EVENT CALL WITH EXPANSE BLOOD BANK STAKEHOLDERS WAS HELD AT MEDICAL INFORMATION TECHNOLOGY, INC. ON MONDAY, MARCH 24, 2025, TO DISCUSS THE DETAILS OF THE ISSUE AND IMPACT TO OUR MEDICAL DEVICE PRODUCTS, AND IT WAS DETERMINED THAT THE ISSUE WAS A PRIORITY 2 WITH A POTENTIALLY HIGH SEVERITY. THE COMPLAINT RELATED TO THIS MDR IS ATTACHED TO THE CORRECTION REPORT 3009404844-04/07/2025-001-C. AFTER RIGOROUS IN-HOUSE TESTING, THE PREVIOUSLY CODED SOFTWARE CORRECTION WAS ORIGINALLY MADE AVAILABLE FOR DELIVERY TO CUSTOMERS ON FEBRUARY 13, 2025. AT THAT TIME, THE CORRECTION WAS KNOWN TO FIX AN ISSUE IN MEDICAL INFORMATION TECHNOLOGY INC.'S EXPANSE PHARMACY PRODUCT WHICH WAS REPORTED BY A DIFFERENT CUSTOMER. THERE WAS NO INDICATION AT THAT POINT THAT THE EXPANSE BLOOD BANK UNIT LABEL BARCODE SCANNING ISSUE EXISTED OR WOULD ULTIMATELY ALSO BE FIXED BY THE SAME CORRECTION. IT WAS ON MARCH 27, 2025, THAT PRIORITY EVENT NOTIFICATIONS WERE E-MAILED TO IMPACTED EXPANSE BLOOD BANK CUSTOMERS WITH DETAILS ABOUT THE ISSUE AND A REQUEST FOR CHANGE CONTROL TO DELIVER THE CORRECTION TO THE CUSTOMER'S ENVIRONMENT. MEDITECH PROVIDED THE FOLLOWING WORKAROUND FOR CUSTOMERS: UNTIL THE CHANGE TO ADDRESS THE ISSUE IS DELIVERED, USERS SHOULD SCAN BARCODES SLOWLY AND VISUALLY COMPARE THE ENTERED NUMBERS WITH THOSE ON THE LABEL OR BAG. WE ALSO ENCOURAGE EXPEDITING TESTING AND DEPLOYMENT OF THIS CHANGE TO LIVE. NO PATIENT HARM HAS BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    AN ISSUE IS OCCURRING WHEN SCANNING THE UNIT BAR CODES OF BLOOD PRODUCTS INTO INVENTORY WHERE MIS-SCANS RESULTED IN THE UNITS BEING INITIALLY ENTERED INTO INVENTORY WITH THE INCORRECT BLOOD TYPE. ONE OF MEDICAL INFORMATION TECHNOLOGY, INC.'S CUSTOMERS REPORTED THAT USERS WERE ENCOUNTERING ERRORS WHEN SCANNING BARCODES IN EXPANSE BLOOD BANK. THE CUSTOMER PROVIDED AN EXAMPLE WHERE A RISK TO PATIENT SAFETY WAS IDENTIFIED. IN THE EXAMPLE, THE USER DESCRIBED SCANNING RED BLOOD CELL UNITS INTO INVENTORY WHERE MIS-SCANS RESULTED IN THE UNITS BEING INITIALLY ENTERED WITH THE WRONG BLOOD TYPE. THE USER CAUGHT THE ERROR WHEN ENTERING THE UNIT BLOOD GROUPING, DELETED THE SAMPLES AND THE UNITS FROM THE SYSTEM. AT THAT POINT THE USER REPEATED THE PROCESS AND SUCCESSFULLY SCANNED THE UNIT'S BLOOD TYPE INTO THE SYSTEM. IT IS IMPORTANT TO NOTE THERE ARE MULTIPLE FACTORS CONTRIBUTING TO THIS ISSUE OCCURRING INCLUDING: NETWORK SPEED, NUMBER OF USERS ACCESSING THE SYSTEM, AND DEVICE PERFORMANCE. THE ISSUE IMPACTS MEDICAL INFORMATION TECHNOLOGY, INC.'S EXPANSE BLOOD BANK CUSTOMERS UTILIZING THE WEB PRESENTATION LAYER (WPL) USER INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613432 EXPANSE BLOOD BANK EXPANSE BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE RELEASES 2.1 & 2.2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown