BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPANSE BLOOD BANK

    MDR report key: 23843359 · Received December 18, 2025

    Report

    Report Number
    3009404844-2025-00005
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    UDI-DI
    00863529000148
    PMA / PMN Number
    BK180219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDITECH RESOLVED THE ISSUE AND MADE RECOMMENDATIONS PRIMARILY THROUGH IMMEDIATE TECHNICAL FIXES, CORRECTIVE ACTIONS WITH THE CUSTOMER, AND SUBSEQUENT KNOWLEDGE BASE SHARING AND INTERNAL EDUCATION. RESOLUTION AND CORRECTIVE ACTIONS (TECHNICAL FIX). THE IMMEDIATE RESOLUTION FOCUSED ON CORRECTING THE CONFIGURATION ERRORS THAT PERMITTED THE TRANSFUSION OF THE CONTAMINATED UNIT AT (B)(6): IDENTIFICATION OF ROOT CAUSE: THE PROBLEM WAS DETERMINED NOT TO BE A DEFECT IN THE CORE SOFTWARE, BUT RATHER SETUP AND CUSTOMER VALIDATION ERRORS STEMMING FROM THE IMPROPER CONFIGURATION OF THE TEST DICTIONARY AND BLOOD BANK CALCULATIONS BY THE AGK TEAM. TECHNICAL SESSION AND DEPLOYMENT: A TECHNICAL SESSION WAS HELD INVOLVING BOTH MEDITECH SOUTH AFRICA (MTSA) AND AGK TEAMS. DURING THIS SESSION, THE TEAM REVIEWED THE POINTS OF FAILURE, WHICH INCLUDED CALCULATIONS THAT FAILED TO TRIGGER CONFIRMATORY TESTS AND THE FUNCTION THAT MOVES THE UNIT STATUS TO "CONTAMINATED". SUCCESSFUL IMPLEMENTATION: CALCULATIONS WERE SET UP AND SUCCESSFULLY TESTED IN THE TEST SYSTEM AND SUBSEQUENTLY IN THE LIVE SYSTEM. THIS IMPLEMENTED THE NECESSARY SAFEGUARDS TO PREVENT THE FUTURE ERRONEOUS RELEASE OF INFECTIOUS BLOOD. MITIGATION OF EXISTING RISK: IN ADDITION TO THE TECHNICAL FIX, MTSA AND AGK IMMEDIATELY RAN A REPORT TO LOCATE ALL EXISTING UNITS WITH REACTIVE SCREEN RESULTS. THEY CONFIRMED THAT ALL 32 UNITS OF CONTAMINATED BLOOD WERE ACCOUNTED FOR, AND THE UNITS NOT ALREADY TRANSFUSED WERE QUARANTINED OR DESTROYED. RECOMMENDATIONS AND FOLLOW-UP EDUCATION. THE FORMAL OUTCOME EMPHASIZED THAT THE PRIMARY CORRECTIVE STEP WAS INSTRUCTING THE CUSTOMER ON PROPER SYSTEM SETUP. MEDITECH FORMALIZED THIS INTO SEVERAL RECOMMENDATIONS AND SHARED KNOWLEDGE: 1. CUSTOMER-SPECIFIC EDUCATION: STAFF AT MTSA WORKED CLOSELY WITH AGK TO PROVIDE EDUCATION ON HOW TO PROPERLY CONFIGURE BBK CALCULATIONS AND DICTIONARIES. THE AGK TEAM AGREED TO MONITOR THE CORRECTED SYSTEM GOING FORWARD. 2. GENERAL KNOWLEDGE SHARING: MEDITECH EMPHASIZED THE CORRECTED SETUP PROCESS FOR ALL CUSTOMERS THROUGH KNOWLEDGE BASE ARTICLES, SPECIFICALLY DISTRIBUTING: A KNOWLEDGE BASE ARTICLE (ARTICLE ID 28129) DETAILING THE "CALCULATION TO MAKE UNITS AND ASSOCIATED UNITS, COMPONENTS, ALIQUOTS QUARANTINED OR CONTAMINATED". A BLOOD BANK (BBK) VALIDATION GUIDE TITLED, "QUARANTINE DONATED UNIT AND INACTIVATE DONOR". 3. INTERNAL BEST PRACTICE: DURING THE INVESTIGATION, MEDITECH STAFF NOTED THAT THE NON-NUMERIC RESULT 'REACTIVE' FOR THE DHBSAG TEST DID NOT HAVE THE ABNORMAL/CRITICAL (ABN/CRI) FLAG SET AND RECOMMENDED THIS BE UPDATED.

    Description of Event or Problem · 0

    THE ADVERSE EVENT (AE) INVOLVED A USER CONFIGURATION ERROR INVOLVING MEDICAL INFORMATION TECHNOLOGY, INC.'S EXPANSE BLOOD BANK APPLICATION THAT RESULTED IN A PATIENT RECEIVING A CONTAMINATED UNIT OF BLOOD, SPECIFICALLY A UNIT THAT TESTED REACTIVE FOR THE HEPATITIS B VIRUS NAT TEST. THE HOSPITAL ((B)(6)) HAD RECENTLY IMPLEMENTED NEW PROCEDURES FOR DONOR BLOOD SCREENING WHICH INCLUDED NUCLEIC ACID TESTING (NAT). DUE TO THE HOSPITAL'S IMPROPER CONFIGURATION OF THE TEST DICTIONARY AND DEFICIENT BLOOD BANK CALCULATIONS, THE AUTOMATED SAFEGUARDS THAT SHOULD HAVE PROTECTED THE PATIENT FAILED. THIS FAILURE MEANT THE CONTAMINATED BLOOD UNIT WAS NOT PROPERLY MARKED AS "CONTAMINATED" OR REMOVED FROM CIRCULATION, REMAINING AVAILABLE FOR PATIENT ASSIGNMENT, AND WAS SUBSEQUENTLY TRANSFUSED TO A PATIENT, RESULTING IN HARM. ALTHOUGH 32 CONTAMINATED UNITS WERE FOUND AT THE ORGANIZATION, ONLY ONE PATIENT WAS HARMED. THE FAILURE WAS ULTIMATELY ATTRIBUTED TO SETUP AND VALIDATION ERRORS BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243794 EXPANSE BLOOD BANK EXPANSE BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY, INC. EXPANSE 2.1 00863529000148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other