BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    MDR report key: 1085053 · Received July 30, 2008

    Report

    Report Number
    2029302-2008-00008
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 25, 2008
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    MMH
    PMA / PMN Number
    BK040065
    Removal / Correction Number
    2029302-2008-00008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOR BOP, THE FOLLOWING WORKFLOW SCENARIOS ARE GIVEN BELOW FOR CLARITY; HOWEVER, THERE ARE OTHER WORKFLOWS IN WHICH THE PROBLEM MAY OCCUR. WORKFLOW 1: CAX IS UTILIZED. WHEN THE ACCESSION NUMBER IS ENTERED USING BOP/BOPW, THE QUALITY ASSURANCE FAILURE "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION" IS NOT GENERATED WHEN "SAVE" IS SELECTED UNDER THE FOLLOWING CONDITIONS: ON A TEST PT THAT QUANTIFIES FOR ELECTRONIC CROSSMATCH, PLACE AN ORDER FOR THREE UNITS OF PACKED CELLS. ACCESS THE ORDER IN BOP. RESULT PT SPECIMEN TESTS SUCH THAT THE PT IS ELIGIBLE FOR CAX. ALLOCATE THREE UNITS OF PACKED CELLS TO THE PT. ENABLE THE COMPATIBILITY REACTION GRIDS. ADD A DIRECT COOMBS TEST (DBS) TO EACH UNIT. ENTER REACTION RESULTS THAT DO NOT MATCH A PATTERN PREVIOUSLY DEFINED IN BLOOD BANK MAINTENANCE (BMA 4 TESTING DEFINITIONS, SUBOPTION 4 REACTION RESULT PATTERNS). INTERPRET THE DBS TEST WITH THE PREVIOUSLY DEFINED MA 4 CODE OF NONE. IN THE EXAMPLE BELOW, CHECK CELLS SHOULD NOT BE NEGATIVE AND THEREFORE A PATTERN WOULD NOT BE DEFINED IN BMA: SEE SCANNED TABLE. NOTE: THIS ISSUE ONLY APPLIES IF NONE IS DEFINED AS A TEXT CODE IN MAINTENANCE (MA) 4. THE SYSTEM WILL NOT ACCEPT NONE AS A RESULT TO TESTS ABR (ABO/RH) AND ARC (ABO/RH RECHECK) UNLESS THE RESULT NONE HAS ALSO BEEN SPECIFICALLY DEFINED AS A BLOOD TYPE TEXT CODE. NOTE: FOR CLIENTS USING COMPUTER ASSISTED CROSSMATCH (CAX) IN BOP, THIS IS ONE OF THE QUALITY ASSURANCE FAILURES THAT DISQUALIFY THE UNIT FROM CAX ELIGIBILITY. IT IS IMPORTANT TO NOTE THAT IF THE EXPECTED QUALITY ASSURANCE FAILURE IS NOT GENERATED, A UNIT MAY INAPPROPRIATELY QUALIFY FOR CAX. QUALITY ASSURANCES WARNINGS ARE MESSAGES THAT ARE GENERATED AS YOU ENTER DATA. THE USER MUST ACKNOWLEDGE ALL WARNINGS. QUALITY ASSURANCES FAILURES ARE MESSAGES THAT ARE GENERATED WHEN THE DATA IS SAVED/FILED. THE USER MUST ACKNOWLEDGE ALL FAILURES AND RESOLVE ALL ISSUES, OR OVERRIDE ALL FAILURES. TO DO SO, YOU NEED TO HAVE APPROPRIATE SECURITY, AND MAY HAVE TO ENTER A REASON CODE. NOTE: FOR SOME QA FAILURES, SECURITY CAN BE DEFINED TO NOT ALLOW AN OVERRIDE. THE QUALITY ASSURANCE WARNING "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION" FOR EACH OF THE UNITS IS NOT GENERATED. SELECT THE "SAVE" OPTION. THE QUALITY ASSURANCE FAILURE "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION" IS NOT GENERATED FOR EACH OF THE UNITS. THE "ELECTRONIC CROSSMATCH ELIGIBILITY REPORT" DIALOG BOX APPEARS, INCORRECTLY INDICATING THE UNITS ARE NOW ELIGIBLE FOR ELECTRONIC CROSSMATCH DUE TO THE FAILURE TO GENERATE "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION." (B) (4).

    Description of Event or Problem · 1

    PRELIMINARY INFO ON THE PROBLEM: IN BLOOD ORDER PROCESSING (BOP/BOPW), WHEN THE UNIT COMPATIBILITY GRID IS ENABLED AND RESULTED WITH A REACTION RESULT PATTERN NOT DEFINED IN BLOOD BANK MAINTENANCE (BMA) AND AN INTERPRETATION TEXT CODE OF NONE IS ENTERED, QUALITY ASSURANCE CHECKING IS NOT GENERATED FOR "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION."

    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