BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS II RAPID TISSUE PROCESSOR

    MDR report key: 13437399 · Received February 3, 2022

    Report

    Report Number
    8020030-2022-00011
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    December 24, 2021
    Report Date
    February 3, 2022
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION OF THE INFORMATION AVAILABLE INDICATES THAT PELORIS LL TISSUE PROCESSOR SERIAL NUMBER (B)(4) IS CONFIGURED FOR XYLENE PROCESSING; AND THE REAGENT IN BOTTLE 14 (XYLENE) WAS REPLACED WITH THE STATION PROPERTIES RESET AT 10:24 ON 24 DECEMBER 2021. THE INFORMATION PROVIDED BY THE COMPLAINANT ON (B)(6) 2022 DETAILS THAT A USE ERROR OCCURRED AT 10:24 ON 24 DECEMBER 2021 DURING REPLACEMENT OF THE REAGENT IN BOTTLE 14 (XYLENE), IN WHICH A USER REPLACED THE REAGENT IN THIS BOTTLE WITH IDA (INDUSTRIAL DENATURED ALCOHOL) RATHER THAN XYLENE, IN ERROR. THE FINAL CLEARING STEP OF A TISSUE PROCESSING PROTOCOL EXECUTED USING A TISSUE PROCESSOR FROM THE PELORIS PRODUCT FAMILY CONFIGURED FOR XYLENE PROCESSING REQUIRES THE USE OF XYLENE. THE MINIMUM REAGENT CONCENTRATION FOR XYLENE USED IN THE FINAL CLEARING STEP OF A TISSUE PROCESSING PROTOCOL IS 95%. IDA IS NOT SUITABLE FOR USE AS A CLEARANT. THE CONSEQUENCES OF USING IDA FOR THE FINAL DEHYDRATION STEP IN A PROCESSING PROTOCOL IS CONTAMINATION OF REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS, AND ULTIMATELY RESULTS IN SUB-OPTIMAL PROCESSING OF PATIENT TISSUE SAMPLES. THE USE OF REAGENT FROM BOTTLE 14, WHICH HAD BEEN FILLED WITH IDA RATHER THAN XYLENE IN ERROR, WOULD HAVE CAUSED CONTAMINATION OF THE WAXES USED FOR THE WAX INFILTRATION STEPS FROM THE FIRST PROCESSING PROTOCOL IN WHICH IT WAS USED, UNTIL ALL CONTAMINATION WAS REMOVED. THE INFORMATION AVAILABLE SHOWS THAT THE REAGENT FROM BOTTLE 14, WHICH HAD BEEN FILLED WITH IDA IN ERROR, WAS USED FOR THE FIRST TIME IN THE FINAL CLEARING STEP OF THE "4 HR" PROTOCOL STARTED IN RETORT B AT 15:33 ON 24 DECEMBER 2021. THE INFORMATION AVAILABLE INDICATES THAT THE REAGENT FROM BOTTLE 14 FILLED WITH IDA AND WAX FROM THE WAX CHAMBERS, WHICH WOULD HAVE BEEN CONTAMINATED DUE TO THE USE ERROR DESCRIBED ABOVE, WOULD HAVE BEEN USED IN A FURTHER FIVE (5) PROCESSING RUNS, WHICH COMPLETED BETWEEN 29 AND 31 DECEMBER 2021. INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THE SIX (6) PROCESSING RUNS FROM THE PATIENT TISSUE SAMPLES INVOLVED WOULD HAVE EXHIBITED SUB-OPTIMAL PROCESSING. THE ROOT CAUSE OF THE SUB-OPTIMAL PROCESSING OF PATIENT TISSUE SAMPLES REPORTED BY THE COMPLAINANT WAS A USE ERROR, WHICH OCCURRED AT 10:24 ON 24 DECEMBER 2021 DURING REPLACEMENT OF THE REAGENT IN BOTTLE 14 (XYLENE), IN WHICH A USER REPLACED THE REAGENT IN THIS BOTTLE WITH IDA (INDUSTRIAL DENATURED ALCOHOL) RATHER THAN XYLENE, IN ERROR.

    Description of Event or Problem · 0

    THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS IN RELATION TO PELORIS II RAPID TISSUE PROCESSOR SERIAL NUMBER (B)(4) AND THE FOLLOWING INFORMATION WAS DOCUMENTED: "ALCOHOL IN THE WAX. NOT SURE IF THEY HAVE PUT IT IN THE WRONG BOTTLE". ON (B)(6) 2022, THE COMPLAINANT DOCUMENTED THE FOLLOWING INFORMATION IN RELATION TO THE ON-SITE EVALUATION CONDUCTED IN RELATION TO THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT: "BRITTLE PROSTATE BIOPSIES NOTICED AT EMBEDDING, MICROTOMY AND SUB-OPTIMAL PROCESSING NOTICED AT SLIDE ISSUE. VISUALLY CHECKED REAGENTS AND FOUND A POOL OF REAGENT FLOATING ON TOP OF THE WAX- THOUGHT TO BE IDA. MOST RECENT BOTTLE TO BE CHANGED WAS BOTTLE 14 - CHECKED CONTENTS AND FOUND TO BE IDA WHEN IT SHOULD HAVE BEEN XYLENE. WITH THIS BEING THE MOST PURE IT WAS THE LAST REAGENT TO BE USED ON ALL RUNS PRIOR TO WAX BETWEEN 24/12/21 AND 31/12/21 APPROXIMATELY 5 RUNS. CONTACTED LEICA, ENGINEER ATTENDED AND FLUSHED LINES AND PIPES WITH XYLENE. IDA REPLACED WITH XYLENE. TEST RUN PERFORMED ON EACH RETORT AND SLIDES MICROSCOPICALLY CHECKED BY TECHNICAL STAFF. MACHINE PUT BACK INTO ROUTINE USE." THE COMPLAINANT FURTHER DETAILED THAT THE TISSUE ARTEFACT WAS "SOME LOSS OF NUCLEAR DETAIL, BRITTLE TISSUE", THE PATIENT TISSUE TYPES INVOLVED WERE "PROSTATE NEEDLE CORES MOST AFFECTED, OTHER TISSUES INCLUDE BREAST CORES AND OTHER DIAGNOSTIC BIOPSIES, THE SIZE OF THE AFFECTED PATIENT TISSUE SAMPLES WAS "LARGEST WAS APPROX. 5 X 4 X 3MM AND THE AFFECTED PATIENT TISSUE SAMPLES HAD NOT BEEN RE-PROCESSED. ON 08 JANUARY 2022, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE DEPUTY LABORATORY MANAGER IN RELATION TO THE PATIENT IMPACT/OUTCOME FOR THE PATIENT CASES INVOLVED IN THIS EVENT: "...THERE WAS NO PATIENT HARM, NO FAILED RUNS AND THE INCIDENT OCCURRED DUE TO USER ERROR" AND ALL PATIENT CASES INVOLVED IN THIS EVENT WERE DIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176090 PELORIS II RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown