BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 7031958 · Received November 14, 2017

    Report

    Report Number
    8020030-2017-00081
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 6, 2017
    Report Date
    October 16, 2017
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY.LTD
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INSTRUMENT LOGS SHOWS THAT THE FOLLOWING REAGENTS ONLY WERE REPLACED BETWEEN 06 OCTOBER 2017 AND 20 OCTOBER 2017: THE WAX IN WAX CHAMBER 2 WAS REPLACED ON 06 OCTOBER 2017; THE REAGENT IN BOTTLE 14 (XYLENE) WAS REPLACED ON 06 OCTOBER 2017; AND THE REAGENT IN BOTTLES 3 (ETHANOL), 4 (ETHANOL), 9 (ETHANOL) AND 2 (FORMALIN) WERE REPLACED ON 16 OCTOBER 2017. THE REAGENT IN BOTTLE 10 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP IN THREE (3) PROTOCOLS, WHICH COMPLETED ON 09 OCTOBER 2017, 20 OCTOBER 2017 AND 23 OCTOBER 2017 COMPRISING SIX (6), 90 AND 270 CASSETTES RESPECTIVELY, IN ADDITION TO THE "2 HR RAPID PROCESS" PROTOCOL STARTED IN RETORT B AT 09:36AM ON 06 OCTOBER 2017 AND THE "ROUTINE OVERNIGHT 1" PROTOCOL STARTED IN RETORT B AT 16:42PM ON 05 OCTOBER 2017 FROM WHICH SUB-OPTIMAL TISSUE PROCESSING HAD BEEN IDENTIFIED ON 06 OCTOBER 2017. THE INFORMATION AVAILABLE INDICATES THAT THE INSTRUMENT FUNCTIONED AS DESIGNED BETWEEN 06 AND 20 OCTOBER 2017. THE INVESTIGATION FINDINGS SUGGEST THAT THE ROOT CAUSE OF THE ADDITIONAL SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT ON 10 NOVEMBER 2017 IS THE CONTINUED USE OF THE REAGENT FROM BOTTLE 10 (ETHANOL) AT A CONCENTRATION LESS THAN 98%, WHICH IS THE MINIMUM REQUIRED FOR THE FINAL DEHYDRATION STEP IN A PROTOCOL, FOR THE FINAL DEHYDRATION STEP IN THREE (3) PROTOCOLS WHICH COMPLETED ON 09 OCTOBER 2017, 20 OCTOBER 2017 AND 23 OCTOBER 2017. THE CONSEQUENCES OF USING REAGENT 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.

    Additional Manufacturer Narrative · 1

    BOTTLE 10 (ETHANOL) WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR APPROXIMATELY SIX (6) SECONDS AT 14:57PM ON (B)(6) 2017, WHICH IS NOT SUFFICIENT TIME TO REPLACE THE REAGENT; AND THE STATION PROPERTIES FOR BOTTLE 10 (ETHANOL) WERE RESET. THIS ACTION SET THE ETHANOL CONCENTRATION IN BOTTLE 10 TO THE DEFAULT VALUE OF 100% CONFIGURED IN THE REAGENT TYPES DEFINITION. HOWEVER, THE ACTUAL CONCENTRATION OF THE REAGENT IN BOTTLE 10 (ETHANOL) REMAINED UNCHANGED AT 67.5%, BECAUSE THE BOTTLE HAD NOT BEEN REMOVED FROM THE INSTRUMENT FOR SUFFICIENT TIME TO REPLACE THE REAGENT. THE INSTRUMENT SOFTWARE USES REAGENT CONCENTRATION TO SELECT REAGENT STATIONS WHEN A PROTOCOL IS SCHEDULED. 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; AND 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, THE REAGENT IN BOTTLE 10 (ETHANOL) WAS USED FOR THE FIRST TIME IN THE FINAL CLEARING STEP OF THE "ROUTINE OVERNIGHT 1" PROTOCOL STARTED IN RETORT B AT 16:42PM ON (B)(6) 2017. BOTTLE 10 (ETHANOL) WAS ALSO SUBSEQUENTLY USED IN THE FINAL DEHYDRATION STEP OF THE "2 HR RAPID PROCESS" PROTOCOL STARTED IN RETORT B AT 09:36AM ON (B)(6) 2017, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR ETHANOL IS 98%. THE CONSEQUENCES OF USING REAGENT 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. ALTHOUGH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT FROM THE "2 HR RAPID PROCESS" PROTOCOL COMPRISING 24 CASSETTES STARTED IN RETORT B AT 09:36AM ON (B)(6) 2017 ONLY, THE QUALITY OF TISSUE PROCESSING FROM THE "ROUTINE OVERNIGHT 1" PROTOCOL COMPRISING 180 CASSETTES STARTED IN RETORT B AT 16:42PM ON (B)(6) 2017 WOULD ALSO HAVE BEEN ADVERSELY IMPACTED, BECAUSE THE REAGENT IN BOTTLE 10 (ETHANOL) WAS ALSO USED FOR THE FINAL DEHYDRATION STEP IN THIS PROTOCOL. INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF BOTH THE "2 HR RAPID PROCESS" PROTOCOL STARTED IN RETORT B AT 09:36AM ON (B)(6) 2017 AND THE "ROUTINE OVERNIGHT 1" PROTOCOL STARTED IN RETORT B AT 16:42PM ON (B)(6) 2017. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED AT 14:57PM ON (B)(6) 2017. THE FACTS INDICATE THAT MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 10 (ETHANOL) WAS NOT COMPLETED IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS LL USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARNING: "ALWAYS CHANGE REAGENTS WHEN PROMPTED. ALWAYS UPDATE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT REPLACING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS."

    Description of Event or Problem · 1

    ON 10 NOVEMBER 2017, THE LEICA FIELD SUPPORT SCIENTIST (FSS) WAS NOTIFIED BY THE COMPLAINANT THAT FURTHER SUB-OPTIMAL TISSUE PROCESSING HAD BEEN IDENTIFIED FROM A PROTOCOL RUN IN RETORT B OF PELORIS LL TISSUE PROCESSOR SERIAL NUMBER (B)(4). THE FSS DOCUMENTED THAT THE LABORATORY HAD NOT BEEN ABLE TO REPLACE THE REAGENT IN ALL BOTTLES DESIGNATED AS <ETHANOL> AFTER THE PREVIOUS INSTANCE OF SUB-OPTIMAL TISSUE PROCESSING IDENTIFIED ON 06 OCTOBER 2017 AND REPORTED TO THE FSS ON 16 OCTOBER 2017 DUE TO LACK OF REAGENT AVAILABILITY; BOTTLE 10 WAS AMONG THOSE IN WHICH THE REAGENT HAD NOT BEEN REPLACED; AND THE INSTRUMENT WAS IN ROUTINE USE IN THE LABORATORY. ON 01 DECEMBER 2017, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION FROM THE COMPLAINANT THAT: "IT HAS TAKEN TIME TO ESTABLISH WHICH PATIENTS HAVE BEEN AFFECTED. I THINK IN THE END IT WAS ONLY TWO DESPITE THE LARGE NUMBER OF BLOCKS IMPACTED." CONFIRMATION AS TO THE NATURE OF THE PATIENT IMPACT AND AN IDENTIFIER, GENDER AND AGE OR DATE OF BIRTH WAS REQUESTED, BUT HAS NOT BEEN RECEIVED AS AT 08 DECEMBER 2017.

    Description of Event or Problem · 1

    A LEICA FIELD SUPPORT SCIENTIST (FSS) WAS INFORMED "OF A PROCESSING INCIDENT THAT OCCURRED ON THE (B)(6) RESULTING IN HARD/BRITTLE TISSUE AND CONSEQUENTLY THE PATHOLOGIST HAS RECOMMENDED RE-BIOPSY OF TWO PATIENTS" DURING A VISIT TO THE LABORATORY FOR AN UNRELATED MATTER ON (B)(6) 2017. THE FSS DOCUMENTED INFORMATION PROVIDED BY THE COMPLAINANT THAT THE SUB-OPTIMAL TISSUE PROCESSING REPORTED HAD BEEN DERIVED FROM A 2 HOUR FACTORY PROTOCOL COMPRISING 24 CASSETTES, WHICH STARTED IN RETORT B AT 09:30AM ON (B)(6) 2017. ON (B)(4) 2017, LEICA BIOSYSTEMS (B)(4) RECEIVED THE FOLLOWING INFORMATION FROM THE COMPLAINANT: "A NUMBER OF DIAGNOSTIC BIOPSY CASES HAVE BEEN AFFECTED BY THE POOR PROCESSING: SPECIFICALLY A BLADDER BIOPSY, A PROSTATE BIOPSY AND MULTIPLE BREAST BIOPSIES FOR 2 PATIENTS - 4 PATIENTS IN TOTAL HAVE BEEN AFFECTED. ALL PATIENTS WILL REQUIRE REPEAT BIOPSIES. THIS WILL RESULT IN A DELAY IN DIAGNOSIS AND FURTHER DISTRESS FOR THE PATIENTS AS THEY WILL HAVE TO UNDERGO PAINFUL, INVASIVE PROCEDURES. IN THE CASE OF THE PROSTATE BIOPSY THERE WILL BE A RISK OF INFECTION THAT IS ASSOCIATED WITH THIS PROCEDURE. THE BREAST BIOPSIES INVOLVED WERE SAMPLES AS PART OF THE NHS BREAST CANCER SCREENING PROGRAMME, AND AS SUCH WILL HAVE TO BE LOGGED AS A SCREENING INCIDENT. THE IMPACT ON THESE PATIENTS LONG TERM CARE IS NOT KNOWN AT THIS TIME". ON 23 OCTOBER 2017, LEICA BIOSYSTEMS (B)(4) RECEIVED AN IDENTIFIER, AGE AND GENDER FOR EACH OF THE FOUR (4) PATIENTS FOR WHOM DIAGNOSTIC BIOPSY CASES WERE AFFECTED BY THE POOR PROCESSING. REFER TO MFR. REPORT #8020030-2017-00082; #8020030-2017-00083; AND #8020030-2017-00084 FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806728 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY.LTD PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other