BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH MAGIC BLOOD BANK

    MDR report key: 975127 · Received March 6, 2006

    Report

    Report Number
    1222805-2006-00001
    Event Type
    Malfunction
    Date Received
    March 6, 2006
    Date of Event
    January 27, 2006
    Report Date
    March 1, 2006
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL- 5.4, 5.5, 5.6. THE SOFTWARE CORRECTION MODIFIES THE PROGRAMS WHICH CHECKS PT BLOOD TYPE FOR MERGING PT RECORDS. EACH OF THE LAB DATABASES WILL NOW PASS ONE OF THE FOLLOWING VALUES TO THE MEDICAL RECORDS MERGE: AN ERROR CODE IF THERE IS A BLOOD TYPE MISMATCH BETWEEN THE SELECTED MEDICAL RECORDS WITHIN ANY DATABASE. IF THERE IS ONLY ONE LOCAL HISTORY, THAT HISTORY'S BLOOD TYPE, OR NIL IF IT HAS NONE. IF THERE IS AT LEAST ONE BLOOD TYPE, THE BLOOD TYPE. IF THERE ARE TWO RECORDS AND NEITHER HAS A BLOOD TYPE, THE TEMPORARY BLOOD TYPE. IF THERE ARE NO BLOOD TYPES AND NO TEMP BLOOD TYPES, NIL. THE MEDICAL RECORDS MERGE NOW USES THE VALUES SENT FROM EACH OF THE LAB DATABASES TO COMPARE THE BLOOD TYPES ACROSS MULTIPLE LAB DATABASES CORRECTLY. IF THERE IS A DISCREPANCY, THE MERGE IS PREVENTED. IN ADDITION, TO CORRECT DATA IN HOSP SYSTEMS, CUSTOMERS WILL RECEIVE A LISTING OF SUSPECT PT RECORDS TO REVIEW FOR DISCREPANCIES AND RESOLVE. THE METHOD FOR IDENTIFYING RECORDS WILL CHECK ANY BBK HISTORY WITH A MERGE, CHECK ALL OTHER LAB DATABASES FOR OTHER BBK HISTORIES FOR THE SAME MEDICAL RECORD, COMPARE BLOOD TYPES AMONG ALL SUCH HISTORIES, AND RETURN A LISTING OF ALL MEDICAL RECORDS WITH BLOOD TYPE DISCREPANCIES. DEVICE EVALUATED BY MFR. THE MAGIC BLOOD BANK MODULE AT THE CUSTOMER LOCATION IS AVAILABLE TO MEDITECH STAFF THROUGH A DIAL-UP CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE DATABASES WITH THE SAME VERSION OF THE SOFTWARE. A "TEST" DATABASES FOR RESEARCH, TESTING, AND VALIDATION; AND A "LIVE" DATABASE USED FOR RECORDING DAILY OPERATIONS OF THE HOSP'S BLOOD BANK. INVESTIGATION FOUND THE SOFTWARE ERROR IN THE HOSP'S USER-SITE TEST DATABASE AND IN MEDITECH'S OWN IN-HOUSE CONTROLLED TESTING ENVIRONMENT. THE ERROR OCCURRED ONLY IN THE FOLLOWING SITUATION: THE HEALTHCARE ORGANIZATION MUST BE SET UP WITH MULTIPLE FACILITIES OF DATABASE CONFIGURATION MUST INCLUDE ONE MEDICAL RECORDS DATABASE LINKING TO TWO LAB DATABASES. THE MEDICAL RECORDS BEING MERGED MUST HAVE PT VISITS IN BOTH LAB DATABASES. THE MEDICAL RECORDS BEING MERGED MUST HAVE BOTH BLOOD BANK HISTORICAL DATA. THE MEDICAL RECORDS BEING MERGED MUST HAVE DIFFERENT BLOOD TYPES. MEDITECH'S BLOOD BANK INTERNAL REVIEW BOARD EVALUATED THE REPORT OF THE SOFTWARE ERROR. THE SEVERITY, LIKELIHOOD, AND DETECTABILITY WERE ANALYZED. THE SEVERITY OF THE ERROR WAS RATED AS HIGH, BASED ON THE POSSIBILITY THAT UNSUITABLE BLOOD PRODUCT COULD BE RELEASED IF THE HEALTHCARE PROFESSIONAL RELIED ONLY ON THE HISTORICAL RECORD OF BLOOD TYPE. STEPS FOR CORRECTIVE AND PREVENTIVE ACTIONS WERE INITIATED PER MEDITECH'S ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    MEDITECH HAS IDENTIFIED A SAFETY CONCERN WITH VERSIONS 4.9, 5.4 AND 5.5 OF THE MAGIC BLOOD BANK SOFTWARE. THESE VERSIONS COULD MALFUNCTION, RESULTING IN INCORRECT PT HISTORICAL DATA. THE CUSTOMER RECENTLY RECEIVED A SOFTWARE UPDATE AND WAS VALIDATING THE BLOOD BANK SOFTWARE IN A TEST DATABASE. IN EARLY 2000, THE INFO SYSTEMS TESTER PERFORMED A MERGE OF TWO TEST PT ACCOUNTS WITH BLOOD BANK DATA, INCLUDING HISTORICAL BLOOD TYPE. ACCORDING TO THE VALIDATION SCRIPT, A WARNING MESSAGE SHOULD HAVE DISPLAYED AND THE TESTER PREVENTED FROM COMPLETING THE MERGE. OUR INVESTIGATION FOUND THAT THE MALFUNCTION COULD OCCUR ONLY WITH A SPECIFIC MULI-FACILITY DATABASE CONFIGURATION WHERE ONE MEDICAL RECORDS DATABASE REFERENCES TWO LAB DATABASES. THE MALFUNCTION HAS NOT BEEN REPORTED AS AFFECTING ANY ACTUAL HOSPITAL PTS. THE POTENTIAL FOR MISDIAGNOSIS BASED ON AN INCORRECT HISTORICAL BLOOD TYPE WAS DEEMED SERIOUS. COMPARISON OF HISTORICAL RECORDS WITH CURRENT RECORDS ARE REQUIRED PRIOR TO A TRANSFUSION. INCORRECT HISTORICAL RECORDS COULD LEAD TO MISDIAGNOSIS OR DELAY WHILE DISCREPANCIES ARE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH MAGIC BLOOD BANK MMH SOFTWARE, BLOOD BANK,STANDALONE PRODUCT MMH MEDICAL INFORMATION TECHNOLOGY, INC. 4.9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other