BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BLOOD BANK SOFTWARE

    MDR report key: 2796715 · Received February 21, 2011

    Report

    Report Number
    1222805-2011-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK080037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE BLOOD BANK SOFTWARE AND DATABASE AT THE CUSTOMER LOCATION IS AVAILABLE TO MEDITECH STAFF THROUGH A SECURE VPN CONNECTION. THE CUSTOMER SITE HAS TWO SEPARATE DATABASES WITH THE SAME VERSION OF SOFTWARE: A TEST DATABASE USED FOR RESEARCH, TESTING, AND VERIFICATION; AND A LIVE DATABASE USED FOR RECORDING THE DAILY OPERATIONS OF THE HOSPITAL'S BLOOD BANK. A CONTROLLED TESTING ENVIRONMENT FOR SOFTWARE OF THE SAME VERSION IS MAINTAINED IN HOUSE BY MEDITECH FOR CUSTOMER MAINTENANCE OF THE STANDARD PRODUCT. MEDITECH ALSO MAINTAINS CONTROLLED, NON-RELEASE TESTING ENVIRONMENTS FOR ALL VERSIONS OF OUR STANDARD SOFTWARE. EVALUATION OF THE MALFUNCTION: INVESTIGATION OF THE SOFTWARE IN THE HOSPITAL'S TEST DATABASE AND IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT WHEN TWO USERS ACCESSED OR EDITED BLOOD BANK SIMULTANEOUSLY, THE TRANSFUSION ADMINISTRATION RECORD ROUTINE FAILED TO RECOGNIZE THE LOCK ON THE DATAFILE. ANY TRANSFUSION DATA ENTERED AFTER THE LOCK IS SET BY THE BLOOD BANK DOES NOT FILE TO THE BLOOD BANK HISTORY. SOFTWARE CORRECTION: MEDITECH CORRECT CLIENT/SERVER RELEASE VERSION 6.0 AND 6.1 SUCH THAT THE TRANSFUSION ADMINISTRATION RECORD WILL NOW RECOGNIZE THE PROCESS LOCKS AND DISPLAY WARNING MESSAGES TO THE USER IF THEY ATTEMPT TO FILE A TRANSFUSION STATUS CHANGE, OR A TRANSFUSION REACTION. THE SYSTEM WILL PREVENT THE USER FROM FILING TRANSFUSION INFO UNTIL THE LOCK IS RELEASED IN BLOOD BANK. ONCE THE BLOOD BANK LOCK IS RELEASED, THE SYSTEM WILL ALLOW THE TRANSFUSION DATA TO BE FILE TO THE APPROPRIATE DATAFILES. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED. NOTIFICATION AND DISTRIBUTION: MEDITECH HAS DISTRIBUTED A NOTIFICATION TO CUSTOMER. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A FACILITY TESTING A SOFTWARE UPDATE REPORTED THAT THE STATUS OF TWO TRANSFUSIONS WAS INCORRECT IN THEIR TEST DATABASE. ALTHOUGH THE TRANSFUSIONIST HAD RECORDED THEM AS COMPLETE, THE TRANSFUSIONS WERE SHOWING AS BEING IN PROGRESS. OUR INVESTIGATION FOUND THAT THIS FAILURE ONLY OCCURRED UNDER THE FOLLOWING CONDITIONS: A TRANSFUSIONIST STARTS RECORDING DATA IN THE TRANSFUSION ADMINISTRATION RECORD FOR A PT; AT THE SAME TIME, A SECOND USER EDITS DATA ON THE PT REQUISITION, SPECIMEN, OR UNIT OF BLOOD BEING TRANSFUSED; THE TRANSFUSIONIST COMPLETED THE TRANSFUSION AND FILES THE TIME THE TRANSFUSION ENDED. IT WAS FOUND THAT UNDER THESE CIRCUMSTANCES, TRANSFUSION DATA DID NOT FILE INTO THE BLOOD BANK HISTORICAL DATAFILE. MISSING DATA IN THE BLOOD BANK HISTORY RECORD COULD INCLUDE TRANSFUSION REACTIONS. OUR ANALYSIS CONCLUDED THAT, IF THIS FAILURE WERE TO OCCUR IN A LIVE ENVIRONMENT, MISSING TRANSFUSION REACTION DATA IN THE BLOOD BANK HISTORY RECORD COULD CONTRIBUTE TO PT HARM: TREATMENT OF THE PT TO COUNTERACT THE REACTION COULD BE DELAYED. ORDERS ON THE PT FOR ADDITIONAL BLOOD COULD LEAD TO SELECTION OF INAPPROPRIATE UNIT, RESULTING IN FURTHER TRANSFUSION REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BLOOD BANK SOFTWARE MEDITECH BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY, INC. 6.0 AND 6.1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1