BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITECH BLOOD BANK SOFTWARE

    MDR report key: 2796730 · Received December 23, 2010

    Report

    Report Number
    1222805-2010-00001
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 22, 2010
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY, INC.
    Product Code
    MMH
    PMA / PMN Number
    BK080037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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 INHOUSE BY MEDITECH FOR CUSTOMER MAINTENANCE OF THE STANDARD PRODUCT. MEDITECH ALSO MAINTAINS CONTROLLED, NON-RELEASED 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 THE MALFUNCTION COULD POTENTIALLY SEVERITY OF A DELAY WAS CONSIDERED. MEDITECH HAS DISTRIBUTED A NOTIFICATION TO CUSTOMERS. MEDITECH PROVIDED CUSTOMERS WITH GUIDANCE FOR PREVENTING FURTHER ISSUES FROM OCCURRING, PRIOR TO RECEIVING THE CODING SOLUTION: IMPACTED FACILITIES WERE INSTRUCTED TO RECEIVE SPECIMENS INDIVIDUALLY IN RECEIVE ROUTINES, OR VIA THE ENTER/EDIT REQUISITION ROUTINE. THESE FACILITIES WERE ALSO INSTRUCTED TO SET THEIR SYSTEM TO PROMPT THE USER FOR THE BLOOD BANK WRISTBAND NUMBER AT THE POINT OF ISSUING A UNIT TO CATCH ANY DISCREPANCIES. MEDITECH CORRECTED CLIENT/SERVER RELEASE VERSIONS 5.5, 5.6, 6.0 AND 6.1 SUCH THAT THE BLOOD BANK WRISTBAND CHECK NOW CORRECTLY DETECTS NUMBERS THAT ARE ALREADY IN USE, INCLUDING THOSE ASSOCIATED TO OTHER SPECIMENS IN THE SAME CURRENT RECEIVE BATCH. IF AN ENTERED WRISTBAND IS ALREADY ASSIGNED TO A DIFFERENT PATIENT OR IS CURRENTLY LOCKED, WHETHER BY THE CURRENT SCREEN OR ANOTHER USER'S SESSION, THE ERROR "WRISTBAND NUMBER IN USE" WILL APPEAR AND THE USER WILL NOT BE ABLE TO PROCEED WITHOUT CHANGING THE WRISTBAND TO ONE NOT ALREADY IN USE. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED. MEDITECH HAS EVALUATED THE DEVICE AFTER CORRECTIONS WERE MADE AND DETERMINED THE SOFTWARE IS WORKING AS INTENDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A BLOOD BANK FACILITY REPORTED THAT THEY WERE ABLE TO ASSIGN MULTIPLE PATIENTS THE SAME BLOOD BANK WRISTBAND NUMBER. OUR INITIAL INVESTIGATION FOUND THAT THIS CAN ONLY OCCUR UNDER THE FOLLOWING SYSTEM SETTINGS; REQUIRES A UNIQUE BLOOD BANK WRISTBAND NUMBER FOR EITHER A PATIENT ACCOUNT OR A MEDICAL RECORD NUMBER; AND THE FUNCTION TO RECEIVE SPECIMENS REQUIRES THE USER TO ENTER A BLOOD BANK WRISTBAND NUMBER. WHEN THE USER RECEIVES MULTIPLE SPECIMENS DURING THE SAME NUMBER AT THE BLOOD BANK WRISTBAND PROMPT FOR DIFFERENT PATIENT'S SPECIMENS. THE SYSTEM FAILS TO CHECK THAT THE BLOOD BANK WRISTBAND NUMBER HAS BEEN ASSIGNED TO A SPECIMEN FOR A DIFFERENT PATIENT. THE USER ERROR WOULD RESULT IN THE WRONG WRISTBAND NUMBER BEING ASSIGNED TO A PATIENT'S SPECIMEN. WHILE SPECIMENS CAN BE USED FOR MANY DIFFERENT TESTS, THE CONCERN IS WITH A SPECIMEN INTENDED FOR A CROSSMATCH TEST IN PREPARATION FOR A PATIENT TRANSFUSION. UNDER THE CONDITIONS DESCRIBED, THE WRISTBAND NUMBER ASSOCIATED WITH THE SPECIMEN AND THE CROSSMATCHED UNIT OF BLOOD WOULD NOT MATCH THE WRISTBAND ON THE PATIENT. THE USER WOULD RECEIVE AN ERROR MESSAGE INDICATING THAT THE WRISTBAND NUMBERS DO NOT MATCH WHILE ISSUING A UNIT OR WHEN VERIFYING PATIENT IDENTIFICATION AT BEDSIDE. OUR ANALYSIS CONCLUDED THAT THE CONSEQUENCES OF THE INITIAL USER ERROR COULD CAUSE CONFUSION OVER THE IDENTIFICATION OF THE PATIENT. THE CONFUSION COULD CONTRIBUTE TO A DELAY IN ADMINISTERING A TRANSFUSION WHILE THE TRANSFUSIONIST CONTACTS THE BLOOD BANK FOR CLARIFICATION OF THE WRISTBAND ERROR. THE DELAY IN TREATMENT COULD RESULT IN HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BLOOD BANK SOFTWARE MEDITECH BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY, INC. 5.5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1