BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    MDR report key: 1001891 · Received December 17, 2007

    Report

    Report Number
    2029302-2007-00006
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    June 26, 2006
    Report Date
    December 14, 2007
    Manufacturer
    SUNQUEST INFORMATION SYSTEMS
    Product Code
    MMH
    PMA / PMN Number
    BK040065
    Removal / Correction Number
    2029302-2007-00006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT REPORTED, THE ISSUE FROM A NON-PRODUCTION AREA. NO OTHER CLIENTS HAVE REPORTED THIS ISSUE. IN THE SUNQUEST BLOOD BANK MODULE, A PROBLEM HAS BEEN IDENTIFIED IN BLOOD ORDER PROCESSING (BOP/BOPW) AND BLOOD PRODUCT TESTING (BPT) WHEN RESULT GRIDS ARE ENABLED. IF THE USER ADDS A TEST USING A KEY THAT IS DEFINED WITH A TEST/RESULT COMBINATION, THE SYSTEM DOES NOT TRIGGER THE FOLLOWING QA WARNING/FAILURES WITHIN THE GRID WHEN THERE IS A MISMATCH BETWEEN THE REACTION RESULTS AND THE INTERPRETATION. BOP - "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION." BPT - "PRODUCT REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION."THE PROBLEM ONLY OCCURS IF A KEY IS USED FROM THE SPECIALIZED RESULTING KEYBOARD AND THIS KEY IS DEFINED WITH BOTH A TEST/RESULT COMBINATION AND THE TEST HAS REACTION RESULTS DEFINED. NOTE: IN BOP, THIS ISSUE ONLY OCCURS IN THE COMPATIBILITY WINDOW ON THE ALLOCATION LAB. THE ISSUE DOES NOT OCCUR IN THE SPECIMEN TESTING WINDOW ON THE PATIENT SPECIMEN TAB IN BOP. GRIDS - BLOOD BANK GRIDS ALLOW THE USER TO PLACE REACTION RESULTS ALONG WITH AN INTERPRETATION INTO SPECIALIZED FIELDS (GRIDS) WHICH THEN ARE EVALUATED BY THE SYSTEM TO ENSURE REACTION RESULTS PATTERNS MATCH COULD INCLUDE EITHER A DIFFERENCE BETWEEN THE REACTION RESULTS AND THE INTERPRETATION OR NO REACTION RESULTS AND THE INTERPRETATION. SPECIALIZED KEYBOARDS - ALLOW CLIENTS TO DEFINE A PARTICULAR KEY TO REPRESENT A TEST OR RESULT OR TEST/RESULT COMBINATION TO A PARTICULAR KEY. THIS HELPS TO MINIMIZE KEYSTROKES AND IS DEFINED IN BMA 4 TESTING DEFINITIONS, SUBOPTION 3, KEYBOARD DEFINITIONS. TO TRIGGER GRIDS, THE TEST ADDED VIA THE KEYBOARD MUST HAVE REACTION RESULTS PATTERNS AND INTERPRETATIONS DEFINED IN BLOOD BANK MAINTENANCE, TESTING DEFINITIONS, SUBOPTION 4 REACTION RESULT PATTERNS. WORKLIST - IN BLOOD PRODUCT TESTING, A SPECIALIZED DISPLAY ALLOWS TECHNOLOGIST TO LOAD MULTIPLE UNITS FOR PROCESSING. RESULTING GRIDS ARE AUTOMATICALLY ENABLED IN WORKLIST FORMAT. WORKFLOW: IN FUNCTION BOP/BOPW THE FOLLOWING PRECONDITIONS MUST BE IN PLACE FOR THIS ISSUE TO OCCUR: THE KEYBOARD BEING ACCESSED IN BOP HAS A KEY DEFINED THAT CONTAINS BOTH THE %XM (CROSSMATCH) TEST AND CMP (COMPATIBLE) RESULT. THE USE REACTION RESULTS GRID MUST BE ENABLED (CHECK IN BOX). MAINTENANCE IS DEFINED THAT ALLOWS % XM TEST TO BE ADDED IN THE COMPATIBILITY GRID (BMA 4 TESTING DEFINITIONS, SUBOPTION 5, DELTA AND OTHER TESTS). A BLOOD BANK CROSSMATCH ORDER EXISTS. UNITS ARE CURRENTLY ALLOCATED BUT CROSSMATCH RESULTS ARE PENDING. THE USER IS IN THE ALLOCATION TAB WITH THE CURSOR IN THE ADD UNIT TEST FIELD. THEY SELECT THE KEY ON THE KEYBOARD THAT IS DEFINED WITH BOTH THE %XM TEST AND A CMP RESULT. THE SYSTEM PLACES BOTH THE COMPATIBILITY RESULT IN BOTH THE INTERPRETATION FIELD FOR THE CROSSMATCH (GRID) AND THE TEST RESULT COLUMN. WHEN THE USER TABS OFF THE INTERPRETATION FIELD, THE SYSTEM DOES NOT GENERATE THE QUALITY ASSURANCE WARNING UNIT COMPATIBLY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION AS IT SHOULD. WHEN THE USER SELECTS SAVE THE SYSTEM DOES NOT DISPLAY THE QUALITY ASSURANCE FAILURE UNIT COMPATIBLY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION AS IT SHOULD. IN FUNCTION BPT THE FOLLOWING PRECONDITIONS MUST BE IN PLACE FOR THIS ISSUE TO OCCUR: THE KEYBOARD BEING ACCESSED IN BPT HAS A KEY DEFINED THAT CONTAINS BOTH THE % AS (ANTIBODY SCREEN) TEST AND % NEG (NEGATIVE) RESULT. MUST BE IN WORKLIST MODE. MAINTENANCE IS DEFINED THAT ALLOWS % AS TEST TO BE ADDED IN THE PRODUCT TESTING GRID (BMA 4 TESTING DEFINITIONS, SUBOPTION 5, DELTA AND OTHER TESTS). A UNIT HAS BEEN ENTERED INTO INVENTORY AND PRODUCT TESTING IS PENDING. THE USER ACCESSES THE UNIT TESTING GRID FOR THE UNIT IN BLOOD PRODUCT TESTING (BPT). THEY PLACE THE CURSOR IN THE BLANK FIELD IN THE TEST COLUMN. THE USER SELECTS THE KEY ON THE KEYBOARD THAT IS DEFINED WITH BOTH THE % AS TEST AND A % NEG RESULT. THE ANTIBODY SCREEN TEST IS ADDED, % NEG IS PLACED IN THE RESULT COLUMN OF THE UNIT TESTING GRID AND THE REACTION RESULT GRID APPEARS AT THE BOTTOM OF THE SCREEN. WHEN THE USER TABS OFF THE RESULT FIELD, THE SYSTEM DOES NOT GENERATE THE QUALITY ASSURANCE WARNING PRODUCT REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION AS IT SHOULD. WHEN THE USER SELECTS SAVE THE SYSTEM DOES NOT DISPLAY THE QUALITY ASSURANCE FAILURE PRODUCT REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION AS IT SHOULD. ON 12/14/2007 A PRODUCT SAFETY NOTIFICATION WAS DISTRIBUTED TO CLIENTS WITH SUNQUEST LABORATORY BLOOD BANK MODULE V6.0.1 AND V6.0.2 DISTRIBUTED WITH SUNQUEST LABORATORY V6.1, V6.2 AND V6.3. A TOTAL OF 283 CLIENTS WERE NOTIFIED. A 270 IN THE UNITED STATES AND 13 OUTSIDE THE UNITED STATES. WORK HAS BEGUN ON A REMEDIAL FIX AND WILL BE AVAILABLE TO CLIENTS WITH SUNQUEST LABORATORY BLOOD BANK MODULE V6.0.1 AND V6.0.2 THAT IS DISTRIBUTED WITH SUNQUEST LABORATORY V6.1, V6.2 AND V6.3.

    Description of Event or Problem · 1

    SUPPORT REVIEWED THIS ISSUE ON 11/05/2007 AND ON 11/21/2007, IT WAS DETERMINED TO HAVE PATIENT SAFETY RISK. IN THE SUNQUEST BLOOD BANK MODULE, A PROBLEM HAS BEEN IDENTIFIED IN BLOOD ORDER PROCESSING (BOP/BOPW) AND BLOOD PRODUCT TESTING (BPT) WHEN RESULT GRIDS ARE ENABLED. IF THE USER ADDS A TEST USING A KEY THAT IS DEFINED WITH A TEST/RESULT COMBINATION, THE SYSTEM DOES NOT TRIGGER THE FOLLOWING QA WARNING/FAILURES WITHIN THE GRID WHEN THERE IS A MISMATCH BETWEEN THE REACTION RESULTS AND THE INTERPRETATION. BOP - "UNIT COMPATIBILITY REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION. BPT - "PRODUCT REACTION ENTRY DOES NOT MATCH SYSTEM INTERPRETATION." THE PROBLEM ONLY OCCURS IF A KEY IS USED FROM THE SPECIALIZED RESULTING KEYBOARD AND THIS KEY IS DEFINED WITH BOTH A TEST/RESULT COMBINATION AND THE TEST HAS REACTION RESULTS DEFINED.

    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