BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    MDR report key: 1181443 · Received October 1, 2008

    Report

    Report Number
    2029302-2008-00009
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 24, 2008
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    MMH
    PMA / PMN Number
    BK040065
    Removal / Correction Number
    2029302-2008-00009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT HARM WAS REPORTED. FOR BLOOD ORDER PROCESSING (BOP), THE FOLLOWING WORKFLOW SCENARIO IS GIVEN FOR CLARITY: PREREQUISITES: MUST BE USING LOOK-UP MODE BY 'ACCESSION NUMBER' IN BOP. THE PATIENT BELONGING TO THE FIRST ACCESSION NUMBER HAS A HISTORICAL BLOOD TYPE ON FILE AND UNITS ALLOCATED. THE PATIENT BELONGING TO THE SECOND ACCESSION NUMBER HAS NO HISTORICAL BLOOD TYPE ON FILE AND NO UNITS ALLOCATED. THE FOLLOWING STEPS MAY BE USED TO REPRODUCE THE ISSUE; HOWEVER, IT IS IMPORTANT TO NOTE THAT THIS ISSUE CANNOT BE REPRODUCED ON DEMAND. ENTER THE FIRST ACCESSION NUMBER AND 'SEARCH'. 'CANCEL' OR 'SAVE' THE ACCESSION NUMBER. THE SYSTEM RETURNS TO THE ACCESSION NUMBER LOOK-UP MODE. NOTICE THAT THE PREVIOUS ACCESSION NUMBER DISPLAYS IN BOTH LOOK-UP BOX AND THE LOOK-UP RESULT LIST. ENTER THE SECOND ACCESSION NUMBER IN THE LOOK-UP BOX. NOTICE THAT THE LOOK-UP BOX DISPLAYS THE SECOND ACCESSION NUMBER AND THE LOOK-UP RESULT LIST DISPLAYS THE FIRST ACCESSION NUMBER. CHOOSE THE 'SELECT' BUTTON. THIS ACTION INITIATES THE LOADING OF THE ACCESSION NUMBER DISPLAYED IN THE LOOK-UP RESULT LIST (ACCESSION NUMBER ONE). WHILE THE ACCESSION NUMBER IS LOADING, CHOOSE THE 'SEARCH' BUTTON. THE SECOND ACCESSION NUMBER WILL REPLACE THE FIRST ACCESSION NUMBER IN THE LOOK-UP RESULT LIST. THE SYSTEM WILL NOW ATTEMPT TO LOAD THE SECOND ACCESSION NUMBER WHILE THE FIRST ACCESSION NUMBER IS ALSO LOADING. WHEN BOP FINISHES LOADING, PATIENT TESTING AND UNIT TESTING DATA FROM THE FIRST ACCESSION NUMBER ARE DISPLAYED, HOWEVER, THE SECOND ACCESSION NUMBER'S PATIENT DEMOGRAPHICS ARE DISPLAYED IN THE PATIENT RIBBON. CHOOSE 'SAVE', THE UNITS FROM THE FIRST ACCESSION NUMBER WILL BE ALLOCATED TO THE SECOND ACCESSION NUMBER. THE SYSTEM NOW UPDATES THE BLOOD BANK ADMINISTRATIVE DATA (BAD) FILE OF THE PATIENT ASSOCIATED WITH ACCESSION NUMBER TWO WITH THE BLOOD TYPE OF THE PATIENT FROM ACCESSION NUMBER ONE. NOTE: IF THE PATIENT ASSOCIATED WITH ACCESSION NUMBER TWO HAD A HISTORICAL BLOOD TYPE OR ANTIGEN/ANTIBODY PREVIOUSLY ON FILE, QUALITY ASSURANCE FAILURES FOR BLOOD TYPE AND ANTIGEN/ANTIBODY COMPATIBILITY WOULD OCCUR AT ALLOCATION (BOP) AND ISSUE (BPI) THUS PREVENTING AN INCOMPLETE UNIT FROM BEING ISSUED.

    Description of Event or Problem · 1

    PRELIMINARY INFORMATION ON THE PROBLEM: THE FOLLOWING ISSUE IS ISOLATED TO BLOOD ORDER PROCESSING (BOP) 'ACCESSION NUMBER' LOOK-UP MODE; IT IS IMPORTANT TO NOTE THAT THIS ISSUE MAY NOT BE REPRODUCED ON DEMAND. ONCE THE 'SEARCH' BUTTON IS CHOSEN FOR AN ACCESSION NUMBER, THE SYSTEM ALLOWS ENTRY OF A SECOND ACCESSION NUMBER WITHOUT FIRST CLEARING THE SEARCH RESULTS FROM THE FIRST ACCESSION NUMBER. THIS MAY CAUSE THE SECOND ACCESSION NUMBER DATA TO BE COMBINED WITH THE FIRST ACCESSION NUMBER ON THE SCREEN DISPLAY WHEN THE 'SELECT' BUTTON IS CHOSEN. AS A RESULT, IF DATA IS SAVED, A PT OTHER THAN THE ONE EXPECTED MAY BE UPDATED. THIS ISSUE CANNOT BE REPRODUCED ON DEMAND IN ANY OTHER BLOOD BACK AND GENERAL LABORATORY RESULTING MODULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNQUEST BLOOD BANK AND BLOOD DONOR MMH SUNQUEST INFORMATION SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1