BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 5797419 · Received July 15, 2016

    Report

    Report Number
    8020030-2016-00032
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 16, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTTLE 3 (ETHANOL) WAS REMOVED FROM THE CORRESPONDING SENSOR FOR APPROXIMATELY FOUR (4) MINUTES AT 07:39AM ON (B)(6) 2016, WHICH IS SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT; AND THE STATION PROPERTIES FOR BOTTLE 3 WERE RESET. RESETTING THE REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITION UNLESS AN ALTERNATIVE VALUE IS ENTERED INTO THE INSTRUMENT SOFTWARE BY THE USER; AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER CYCLES AND DAYS TO ZERO. THE PROPERTIES OF THE REAGENT IN BOTTLE 3 PRIOR TO THIS ACTION WERE: ETHANOL CONCENTRATION = 50.9%, CYCLES = 35, CASSETTES = 393 AND DAYS = 223. A USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF 100% WAS TO BE SET FOR BOTTLE 3 (ETHANOL) AT 07:43AM ON (B)(6) 2016. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WERE DERIVED FROM THE "FACTORY 2HR XYLENE FFD" PROTOCOL STARTED IN RETORT A AT 16:44PM ON (B)(6) 2016. THIS PROTOCOL COMPRISED 126 CASSETTES; AND COMPLETED SUCCESSFULLY AT 18:28PM ON (B)(6)2016. THE REAGENT IN BOTTLE 3 (ETHANOL) AND THE WAX IN WAX BATH 3 WERE USED FOR THE FIRST TIME IN THE FINAL DEHYDRATION AND WAX INFILTRATION STEPS RESPECTIVELY OF THE "FACTORY 2HR XYLENE FFD" PROTOCOL STARTED IN RETORT A AT 16:44PM ON (B)(6) 2016. IT IS CONSIDERED UNLIKELY THAT THE USER ACTIONS IN REPLACING THE WAX IN WAX BATH 3 EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED, BECAUSE THE WAX WAS SUCCESSFULLY DRAINED TO WASTE AT 07:31AM ON (B)(6) 2016, PRIOR TO RESETTING THE STATION PROPERTIES AND FILLING THE WAX BATH WITH FRESH WAX ALL OTHER REAGENTS, INCLUDING THE REMAINING WAXES, HAD BEEN USED FOR AT LEAST TWELVE (12) PREVIOUS PROCESSING RUNS WITHOUT REPORTED INCIDENT. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION IN BOTTLE 3 (ETHANOL) WAS TO BE SET TO 100% AT 07:39AM ON (B)(6) 2016, THE COMPLAINANT REPORTED THAT BOTTLE 3 (ETHANOL) HAD ACTUALLY BEEN REFILLED WITH 70% ETHANOL. THIS INFORMATION INDICATES THAT A USE ERROR OCCURRED DURING REPLACEMENT OF THE REAGENT IN BOTTLE 3. THE INSTRUMENT SOFTWARE USES REAGENT CONCENTRATION TO SELECT REAGENT STATIONS WHEN A PROTOCOL IS SCHEDULED; AND THE REAGENT STATION WITH THE LOWEST (IN -THRESHOLD) CONCENTRATION OF A REAGENT GROUP OR TYPE IS SELECTED FOR THE FIRST STEP USING THAT REAGENT GROUP OR TYPE. REAGENT STATIONS OF INCREASING CONCENTRATION ARE USED FOR THE SUCCEEDING PROCESSING STEPS OF THE REAGENT GROUP OR TYPE. REAGENT WITH THE HIGHEST CONCENTRATION IS ALWAYS USED FOR THE FINAL PROCESSING STEP OF A REAGENT GROUP OR TYPE BEFORE CHANGING TO ANOTHER REAGENT GROUP OR TYPE. AS A CONSEQUENCE, BOTTLE 3 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP OF THE "FACTORY 2HR XYLENE FFD" PROTOCOL STARTED IN RETORT A AT 16:44PM ON (B)(6) 2016. THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR ETHANOL IS 98%. THE CONSEQUENCES OF USING ETHANOL AT A CONCENTRATION LESS THAN THE MINIMUM REQUIRED FOR THE FINAL DEHYDRATION STEP IN A PROTOCOL IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS; AND CONTAMINATION OF REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS, ULTIMATELY RESULTING IN SUB-OPTIMAL TISSUE PROCESSING. INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THE "FACTORY 2HR XYLENE FFD" PROTOCOL STARTED IN RETORT A AT 16:44PM ON (B)(6) 2016. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED DURING REPLACEMENT OF THE REAGENT IN BOTTLE 3 (ETHANOL), PRIOR TO COMMENCEMENT OF THE "FACTORY 2HR XYLENE FFD" PROTOCOL STARTED IN RETORT A AT 16:44PM ON (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    ON 21 JULY 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT: "TO DATE, ONLY ONE OF THE AFFECTED BIOPSIES HAS BEEN RE-BIOPSIED." ON 22 JULY 2016, THE COMPLAINANT PROVIDED THE INITIALS; DATE OF BIRTH AND GENDER OF THE ONE (1) PATIENT WHO HAS UNDERGONE RE-BIOPSY TO DATE.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE SAMPLES. THE COMPLAINANT ADVISED THAT A USER HAD REPLACED THE REAGENT IN BOTTLE 3 WITH 70% ALCOHOL ON (B)(6) 2016; AND HAD INCORRECTLY SET THE REAGENT CONCENTRATION TO 100% IN THE INSTRUMENT SOFTWARE. THE COMPLAINANT FURTHER ADVISED THAT REAGENT STATIONS 3, 4 AND 5 HAD BEEN RE-CONFIGURED FOR REAGENT TYPES "70% ETHANOL", "80% ETHANOL" AND "95% ETHANOL" RESPECTIVELY SUBSEQUENT TO THE OCCURRENCE OF THIS USE ERROR. THE COMPLAINANT ALSO REPORTED THAT ERROR CODE "5000" WAS NOTIFIED BY THE INSTRUMENT SOFTWARE AFTER RE-CONFIGURATION OF THE REAGENT TYPE FOR STATIONS 3, 4 AND 5. ON 28 JUNE 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT THE REPORTING PATHOLOGIST(S) HAD NOTED "PROCESSING ARTEFACT" FOR 14 OF THE 127 TISSUE SAMPLES INVOLVED IN THIS EVENT; AND THE COMMENT THAT: "....A DIAGNOSIS COULD NOT BE CONFIDENTLY MADE AND CLINICAL FOLLOW UP OR RE-EXCISION WAS RECOMMENDED" HAD BEEN INCLUDED IN THE ASSOCIATED REPORTS. ON 07 JULY 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ALTHOUGH RE-BIOPSY OF A PATIENT(S) HAD NOT BEEN PERFORMED, THE AFFECTED PATIENTS WOULD BE MONITORED CLINICALLY AND RE-BIOPSY WOULD BE PERFORMED IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452952 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR