BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2220631 · Received June 22, 2011

    Report

    Report Number
    8020030-2011-00037
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION PROCESS. EVAL OF THE PARTIAL LOGS PROVIDED SHOWS THAT CONFIGURATION OF THE REAGENT STATIONS, THE FINAL REAGENT THRESHOLDS AND THE REAGENT MGMT SETTINGS ENABLED ARE IDENTICAL TO THE MFR RECOMMENDATION. THE MINOR DIFFERENCE IN THE REAGENT CHANGE THRESHOLDS IS NOT CONSIDERED TO HAVE EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL PROCESSING REPORTED. CONFIGURATION OF THE PROTOCOL FROM WHICH SUB-OPTIMAL PROCESSING WAS IDENTIFIED WAS NOT AVAILABLE FROM THE TRUNCATED LOGS. THE LOGS SHOW BOTTLE 9 WAS REMOVED FROM THE INSTRUMENT FOR LESS THAN THE MINIMUM CONFIGURED PERIOD OF 20 SECONDS (3 SECONDS IN THIS INSTANCE), WHICH IS IN TURN LESS THAN THE MINIMUM TIME OF 1 MINUTE REQUIRED FOR AN EXPERIENCED USER TO COMPLETE MANUAL REAGENT REPLACEMENT; AND THAT THE REAGENT STATION WAS RESET. RESETTING THE REAGENT STATION SET THE CONCENTRATION TO THE DEFAULT VALUE OF 100% IN THE SOFTWARE, AND ALSO AUTOMATICALLY RESET THE NUMBER OF CASSETTES PROCESSED, CYCLES AND DAYS TO ZERO. HOWEVER, THE ACTUAL CONCENTRATION OF ETHANOL IN BOTTLE 9 REMAINED AS 69.7%. THE PELORIS USER MANUAL STATES: "ALWAYS UPDATE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT CHANGING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS." THE SCHEDULING ALGORITHM WOULD HAVE SELECTED BOTTLE 9 FOR THE FINAL DEHYDRANT STEP. THE MINIMUM REQUIRED ETHANOL CONCENTRATION FOR THIS STEP IS 98%: AND THE CONSEQUENCES ARE RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH IS NOT DISPLACED IN SUBSEQUENT STEPS AND REAGENT CONTAMINATION, ULTIMATELY RESULTING IN THE SUB-OPTIMAL TISSUE PROCESSING REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING RESULTING IN UNDER-PROCESSED TISSUE FROM A PROTOCOL WHICH COMMENCED AND COMPLETED ON (B)(6) 2011, USING POLARIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). ON (B)(6) 2011, LEICA MICROSYSTEMS WAS ADVISED THAT ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WERE DIAGNOSABLE AND ABLE TO BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1