BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDITECH BLOOD BANK SOFTWARE

    MDR report key: 2624695 · Received November 27, 2007

    Report

    Report Number
    1222805-2007-00001
    Event Type
    Other
    Date Received
    November 27, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 26, 2007
    Manufacturer
    MEDICAL INFORMATION TECHNOLOGY INC
    Product Code
    MMH
    PMA / PMN Number
    BK060029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: THE BLOOD BANK SOFTWARE AND DATABASE 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 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. EVALUATION OF THE PROBLEM: INVESTIGATION OF THE SOFTWARE IN THE HOSPITAL'S TEST DATABASE AND IN MEDITECH'S CONTROLLED TESTING ENVIRONMENT FOUND THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS, BUT THAT AN ADDITIONAL USER WARNING WOULD REDUCE THE RISK OF A POTENTIAL ADVERSE EVENT. THE SYSTEMS DESIGN FOR HANDLING ANTIBODIES AND ANTIGENS IS BASED ON AABB STANDARD 4.3 WHICH REQUIRES THAT INCOMING BLOOD AND COMPONENTS SHALL BE RECEIVED, INSPECTED, AND TESTED, AS NECESSARY BEFORE ACCEPTANCE OR USE. MEDITECH INTERPRETS THE AABB STANDARD FOR THE DESIGN OF THE SOFTWARE TO MEAN THAT: WHEN BLOOD OR BLOOD COMPONENTS ARE RECEIVED, TESTING IS THE MOST ACCURATE WAY TO IDENTIFY THE UNIT'S ANTIGENS AND ANTIBODIES. WHEN BLOOD OR BLOOD COMPONENTS ARE RECEIVED AND ANTIBODIES OR ANTIGENS ARE RECORDED DIRECTLY ON THE UNIT, THE INFO IS HIGHLY LIKELY TO BE ACCURATE BASED ON INSPECTION. AFTER UNITS ARE RECEIVED, WHEN USERS RECORD ANTIGENS OR ANTIBODIES ON THE UNIT HISTORY FILE WITHOUT CONFIRMATORY TESTING, THE INFO IS UNVERIFIED. THEREFORE, WHEN POOLING: A UNIT WHICH HAS BEEN TESTED AND RESULTED FOR ANTIBODIES OR ANTIGENS, THE ANTIBODIES OR ANTIGENS SHOULD BE COPIED TO THE POOLED UNIT, A UNIT WHICH WAS RECEIVED WITH IDENTIFIED ANTIBODIES OR ANTIGENS, THE ANTIBODIES OR ANTIGENS SHOULD BE COPIED TO THE POOLED UNIT, A UNIT WHICH WAS RECEIVED WITHOUT ANY IDENTIFIED ANTIBODIES OR ANTIGENS, HAS NOT BEEN TESTED AND RESULTED FOR ANTIBODIES OR ANTIGENS, AND THE SOURCE OF THE ANTIBODY OR ANTIGEN INFO WAS RECORDED THROUGH A UNIT HISTORY EDIT, THE ANTIBODIES OR ANTIGENS ARE UNVERIFIED AND SHOULD NOT BE COPIED TO THE POOLED UNIT, BUT THE USER SHOULD BE WARNED SO THAT THE UNIT CAN BE CHECKED AND CONFIRMATORY TESTING CAN BE PERFORMED AS NECESSARY. THE SOFTWARE CORRECTION MODIFIES THE PROGRAM USED TO RECORD THE POOLING OF UNITS. IF THERE ARE ANY ANTIBODIES OR ANTIGENS FILED ON THE UNIT'S HISTORICAL DATA, THE FOLLOWING WARNING MESSAGE WILL BE DISPLAYED TO THE USER: "UNITS BEING POOLED CONTAIN ANTIBODIES OR ANTIGENS THAT MAY NOT BE COPIED TO THE POOLED UNIT IF ADDED TO THE UNIT VIA THE HISTORY ROUTINES. COMPARE THE NEWLY POOLED UNIT'S HISTORY AGAINST THE HISTORIES OF THE INDIVIDUAL UNITS TO ENSURE ANTIBODIES OR ANTIGENS PRESENT ON THE NEWLY POOLED UNIT IS/ARE INDEED ACCURATE.

    Description of Event or Problem · 1

    ON (B)(6) 2007, A FACILITY REPORTED THAT DURING SOFTWARE VALIDATION IN THEIR TEST SYSTEM, POOLED UNITS DID NOT SHOW ANTIBODIES OR ANTIGENS FROM THE SOURCE UNIT. RESEARCH REVEALED THAT A SITUATION OCCURS UNDER THE FOLLOWING CONDITIONS: THE USER RECORDS A FREE TEXT ANTIBODY OR ANTIGEN ON THE UNIT HISTORY WITHOUT TESTING THE UNIT TO CONFIRM THE ANTIBODY OR ANTIGEN; THE USER SUBSEQUENTLY POOLS THE UNIT OF BLOOD PRODUCT WITH OTHER UNITS. UNDER THESE CONDITIONS, THE NEWLY POOLED UNIT OF BLOOD WOULD NOT CARRY FORWARD THE ANTIBODY OR ANTIGEN FROM THE SOURCE UNIT. THERE WERE NO REPORTED INSTANCES OF AN ADVERSE EVENT IN A LIVE SYSTEM. ON (B)(6) 2007, MEDITECH DETERMINED THAT ADDITIONAL RISK MITIGATION IS WARRANTED IN MAGIC AND CLIENT SERVER VERSIONS 5.4, 5.5, 5.6 FOR THE FOLLOWING CAUSE: RECORDING AN UNVERIFIED HISTORICAL ANTIBODY OR ANTIGEN ON A UNIT OF BLOOD PRODUCT. ON (B)(6) 2007, MEDITECH DISTRIBUTED A NOTIFICATION TO CUSTOMERS. CODE CHANGES ARE BEING PROVIDED TO ALL CUSTOMERS WHO COULD BE IMPACTED. THE RISK MITIGATION HAS BEEN IMPROVED BY ADDING AN INFORMATIONAL WARNING MESSAGE AT THE TIME A USER RECORDS THE POOLING OF UNITS. MEDITECH HAS EVALUATED THE DEVICE AND DETERMINED THAT THE SOFTWARE IS WORKING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDITECH BLOOD BANK SOFTWARE MEDITECH BLOOD BANK MMH MEDICAL INFORMATION TECHNOLOGY INC 5.4, 5.5, 5.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1