BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPANSE BLOOD BANK

    MDR report key: 21388862 · Received February 14, 2025

    Report

    Report Number
    3009404844-2025-00001
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Report Date
    February 14, 2025
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK180219
    Removal / Correction Number
    3009404844-02/14/2025-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, A MEDITECH CUSTOMER REPORTED THAT MICROBIOLOGY RESULTS HAD THE POTENTIAL TO BE DELETED FROM AN ENTRY SCREEN. MEDITECH DISCUSSED THE ISSUE WITH THE CUSTOMER AND ATTEMPTED TO REPRODUCE THE ISSUE BUT WERE UNSUCCESSFUL. ON (B)(6) 2025, MEDITECH INSTALLED "TRAP CODE" IN THE CUSTOMER'S DIRECTORY TO GATHER MORE INFORMATION ON THE ISSUE. ON (B)(6) 2025, MEDITECH WAS ABLE TO REPRODUCE THE ISSUE IN A CONTROLLED, INHOUSE DEVELOPMENT RING. ALTHOUGH THE ISSUE WAS NOT A SOFTWARE MALFUNCTION IN ANY OF THE MEDICAL DEVICES, THE PROBLEM MANIFESTS ITSELF IN THE LABORATORY (LAB), BLOOD BANK (BBK), MICROBIOLOGY (MIC), GENETICS (GEN) AND ANATOMICAL PATHOLOGY (PTH) PRODUCTS. THE ISSUE WAS CONFIRMED TO BE RELATED TO A TECHNICAL CHANGE THAT WAS IMPLEMENTED IN OUR WEB PRESENTATION LAYER WEB CLIENT WHICH CHANGED HOW THE SYSTEM READS KEYSTROKES. AS OPPOSED TO TAKING ACTION WHEN A KEY IS PRESSED DOWN, ACTIONS ARE ALSO BEING TAKEN AS THE KEY IS RELEASED. THE SOFTWARE CORRECTION WAS IDENTIFIED AND FURTHER EXPANSIVE TESTING CONTINUED DUE TO THE BROAD IMPACT OF THIS ISSUE. PRIORITY EVENT CALLS WERE HELD AT MEDITECH ON (B)(6) 2025 AND (B)(6) 2025 TO DISCUSS THE DETAILS OF THE ISSUE AND IMPACT TO OUR MEDICAL DEVICE PRODUCTS, AND ON (B)(6) 2025, IT WAS DETERMINED THAT THE ISSUE WAS A PRIORITY 1. AT THE TIME MEDITECH SUCCESSFULLY REPRODUCED THE MALFUNCTION ON (B)(6) 2025, A DETAILED REVIEW OF PRIOR CUSTOMER COMPLAINTS WAS PERFORMED WHICH IDENTIFIED SEVERAL COMPLAINTS INVOLVING THE BLOOD BANK PRODUCT FROM LATE (B)(6) 2024. ALL COMPLAINTS RELATED TO THIS MDR ARE ATTACHED TO CORRECTION REPORT 3009404844-02/14/2025-001-C. PRIORITY EVENT NOTIFICATIONS WERE E-MAILED TO THE BLOOD BANK CUSTOMERS ON FEBRUARY 2, 2025 WITH DETAILS ABOUT THE ISSUE AND ANY AVAILABLE WORKAROUNDS. AFTER RIGOROUS IN-HOUSE TESTING, THE SOFTWARE CORRECTION WAS MADE AVAILABLE FOR DELIVERY TO IMPACTED CUSTOMERS ON FEBRUARY 5, 2025. NO PATIENT HARM HAS BEEN REPORTED AS A RESULT OF THIS ISSUE.

    Description of Event or Problem · 0

    AN ISSUE IS OCCURRING WHEREBY ENTERING MULTIPLE KEYS SIMULTANEOUSLY THAT TRIGGER INPUT MAY REMOVE DATA FROM THE FIRST FIELD OF SCREENS WITH MORE THAN ONE FIELD. 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. WHEN THIS OCCURS, IT MAY IMPACT THE BLOOD BANK APPLICATION WHEN CONNECTED VIA THE WEB PRESENTATION LAYER (WPL), INCLUDING BUT NOT LIMITED TO THE FOLLOWING SCENARIOS: EXPANSE BLOOD BANK (BBK) THIS MAY OCCUR IN ANY SCREEN WITH TWO OR MORE FIELDS. WHEN THIS OCCURS IN BLOOD BANK (BBK) RESULT ENTRY ROUTINE THE RESULTS OF A TEST OR COMPONENT MAY BE DELETED FROM THE SCREEN IF THE TECHNOLOGIST QUICKLY PRESSES ENTER AFTER ENTERING OR EDITING A RESULT ON THE PRIOR LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982915 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