PELORIS II TISSUE PROCESSOR
Report
- Report Number
- 8020030-2023-00016
- Event Type
- Injury
- Date Received
- May 31, 2023
- Date of Event
- April 27, 2023
- Report Date
- May 31, 2023
- Manufacturer
- LEICA BIOSYSTEMS MELBOURNE PTY. LTD
- Product Code
- IEO
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER EVALUATION OF THE INFORMATION AVAILABLE FOUND THAT THE ROOT CAUSE FOR THE SUB-OPTIMAL PROCESSING OF PATIENT TISSUE SAMPLES REPORTED BY THE COMPLAINANT WAS A USE ERROR, WHICH OCCURRED AT 18:14PM ON 27 APRIL 2023, AS EVIDENCED BY THE VARIANCE BETWEEN THE ETHANOL CONCENTRATION MEASURED IN BOTTLE 8 USING A HYDROMETER OF 69.3% AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE ALGORITHM OF 100%. SPECIFICALLY, A USER FAILED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 8 (ETHANOL) IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN SECTION 5.4.4 OF THE LEICA PELORIS/PELORIS II 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." AT 18:14PM ON (B)(6) 2023, BOTTLE 8 (ETHANOL) WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR FOUR (4) SECONDS, WHICH IS NOT SUFFICIENT TIME TO REPLACE THE REAGENT IN THIS BOTTLE IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN SECTION 5.4.4 OF THE LEICA PELORIS/PELORIS II USER MANUAL ENTITLED <REPLACING REAGENTS-MANUAL>. THE STATION PROPERTIES FOR BOTTLE 8 (ETHANOL) WERE RESET AT 18:14PM ON 27 APRIL 2023, WITH A USER AFFIRMING IN THE INSTRUMENT GRAPHICAL USER INTERFACE (GUI) THAT THE ETHANOL CONCENTRATION IN BOTTLE 8 (ETHANOL) WAS TO BE SET TO THE DEFAULT VALUE OF 100%. DUE TO THE USE ERROR DETAILED, THE ACTUAL ETHANOL CONCENTRATION OF THE REAGENT IN BOTTLE 8 (ETHANOL) REMAINED AT 69.3%. AS 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. DUE TO THE USE ERROR DETAILED, THE REAGENT IN BOTTLE 8 (ETHANOL) WITH AN ETHANOL CONCENTRATION OF 69.3% WAS USED FOR THE FINAL DEHYDRATION STEP IN THE "FACTORY 2HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT A AT 18:18 ON (B)(6) 2023, THE "FACTORY 2HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT B AT 13:06 ON (B)(6) 2023 AND THE "FACTORY 2HR XYLENE STANDARD" SINGLE INSTANCE EDITED PROTOCOL (TO COMMENCE IN THE FINAL DEHYDRATING STEP) STARTED IN RETORT A AT 13:16 ON (B)(6) 2023 FROM WHICH SUB-OPTIMAL PROCESSING OF PATIENT TISSUE SAMPLES WAS REPORTED BY THE COMPLAINANT. THE MINIMUM ETHANOL CONCENTRATION OF 98% REQUIRED FOR USE IN THE FINAL DEHYDRATION STEP OF A PROTOCOL. THE CONSEQUENCES OF USING REAGENT AT A CONCENTRATION LESS THAN THE MINIMUM REQUIRED FOR THE FINAL DEHYDRATION STEP IN A PROTOCOL ARE 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 PROCESSING OF PATIENT TISSUE SAMPLES. REAGENTS CONTAMINATED WITH WATER DUE TO THE USE ERROR DETAILED WERE USED IN THE "FACTORY 2HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT A AT 11:56 ON 28 APRIL 2023, THE "FACTORY 2HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT B AT 13:06 ON 28 APRIL 2023, THE "4 HR BIOPSY" PROTOCOL STARTED IN RETORT B AT 18:32 ON 28 APRIL 2023 AND THE "FACTORY 2HR XYLENE STANDARD" STARTED IN RETORT A AT 18:36 ON 28 APRIL 2023. THE QUALITY OF PROCESSING OF PATIENT TISSUE SAMPLES FROM THESE TISSUE PROCESSING RUNS WOULD ALSO HAVE BEEN SUB-OPTIMAL.
ON (B)(6) 2023, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS AND THE FOLLOWING INFORMATION WAS DOCUMENTED: "RUINED TRANSPLANT KIDNEY BIOPSY OTHER TISSUE SALVAGED; 6PM THURSDAY APR 27,2023 START, END 11PM THURSDAY 2 HR FACTORY XYLENE PROTOCOL. THURSDAY 82 DIFFERENT TYPES OF TISSUE. RET A. KIDNEY BIOPSY UNREADABLE RET B WAS ALSO RUNNING 4 HR BIOPSY, CALLER DID NOT KNOW IF ANY TISSUE AFFECTED. AT START OF BOTH RUNS AT 6PM (6:12PM) FINAL REAGENT CONC. THRESHOLD EXEEDED [SIC] MESSAGE, THEN ABANDONED RUN, BOTTLE 8 PROPERTIES RESET BOTTLE 8 WAS AT 69% FRIDAY AFTERNOON RUNS LOADED SAME PROGRAMS RET B VERY DRY 3 TISSUE RAN ONLY GI, 1 KIDNEY RET A HAD 17 (GI ) HAVE NOT READ THESE YET. APPEARED DRY DURING SECTIONING.USED HYDROMETER TO MEASURE ALCOHOLS WROTE DOWN WHAT CONCENTRATION S WERE SHOWN ON SCREEN. DIFFERENCES BOT 5 ON SCREEN 98% HYDROM [SIC] MEASURED 100%, BOTTLE 6 SCREEN 80% HUDROMETER [SIC] READ 92%, BOTTLE 7 SCREEN 94% HYDR [SIC] READ 99%, BOTTLE 8 SCREEN SHOWED 100 % HYDRO READ 82%. BOTTLE 9 SCREEN 98% HYDRO 100%, BOTTLE 10 SCREEN 89% HYDRO SHOWED 98%." THE COMPLAINANT FURTHER DETAILED THE ETHANOL CONCENTRATION IN BOTTLES 3-10 INCLUSIVE BOTH MEASURED USING A HYDROMETER AND CALCULATED BY THE INSTRUMENT SOFTWARE, FOR WHICH THE VARIANCE BETWEEN THE MEASURED AND CALCULATED ETHANOL CONCENTRATION WAS FOUND TO BE WITHIN THE ACCEPTABLE LIMITS OF +/-5% EXCEPT FOR BOTTLES 6 AND 8. THE MEASURED ETHANOL CONCENTRATION IN BOTTLE 6 WAS REPORTED AS 92% AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE WAS 80% AND THE MEASURED ETHANOL CONCENTRATION IN BOTTLE 8 WAS REPORTED AS 82% AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE WAS 100%. ON 02 MAY 2023, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION PROVIDED BY THE COMPLAINANT TO THE LEICA TECHNICAL SUPPORT: "KIDNEY BIOPSY UNREADABLE...CALLER DID NOT KNOW IF ANY TISSUE AFFECTED." ON 04 MAY 2023, THE ASSIGNED LEICA SR APPLICATION SPECIALIST, CORE HISTOLOGY (FAS) SPOKE TO THE COMPLAINANT AND WASADVISED THAT THE AFFECTED PATIENT TISSUE SAMPLES WERE DERIVED FROM THREE (3) TISSUE PROCESSING RUNS AS FOLLOWS: "STARTED: 27APR23 18:18 ENDED: 28APR23 0:17 FACTORY 2 HR XYLENE STANDARD 28 CASSETTES REORT [SIC] A" PROCESSING RUN, "STARTED: 28APR23 13:06 ENDED: 28APR23 15:46 FACTORY 2 HR XYLENE STANDARD 3 CASSETTES RETORT B" PROCESSING RUN AND "STARTED: 28APR23 13:16 ENDED: 28APR23 14:46 FACTORY 2 HR XYLENE STANDARD 17 CASSETTES RETORT A" PROCESSING RUN; THE TISSUE TYPE OF THE AFFECTED PATIENT SAMPLES TYPE WAS "BIOPSY"; THE SIZE OF THE AFFECTED PATIENT TISSUE SAMPLES WAS "LESS THAN 3MM DIAMETER (2 HR)" RESPECTIVELY AND THE AFFECTED PATIENT TISSUE SAMPLES HAD NOT BEEN RE-PROCESSED. THE FAS ALSO DOCUMENTED THAT BASED ON DISCUSSION WITH THE COMPLAINANT "...TISSUE EFFECTED [SIC] HAPPENED AFTER RESETTING OF ETHANOL BOTTLE 8 (WHICH CORRESPOND TO CUSTOMER FINDINGS)"; AND THE COMPLAINANT ADVISED THE FOLLOWING ACTION WOULD BE TAKEN "...REPLACE ALL REAGENTS (INCLUDING WAX), ENSURE ETHANOL'S ARE GRADED CORRECTLY AND RUN TEST TISSUE." ON 05 MAY 2023, THE ASSIGNED LEICA SR. FIELD APPLICATION SPECIALIST, CORE HISTOLOGY RECEIVED INFORMATION FROM THE COMPLAINANT THAT: "TISSUE: UNDIAGNOSABLE". AS AT 30 MAY 2023, NEITHER AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER FOR THE PATIENT CASE(S) WITH "TISSUE: UNDIAGNOSABLE" NOR INFORMATION AS TO THE IMPACT ON A PATIENT(S) HAS BEEN PROVIDED TO LEICA BIOSYSTEMS DESPITE A DEMONSTRABLE REASONABLE ATTEMPT TO OBTAIN THIS INFORMATION. THE LOCAL LEICA SR. FIELD APPLICATION SPECIALIST, CORE HISTOLOGY REQUESTED THIS INFORMATION FROM THE COMPLAINANT ON 02 MAY 2023 BY TELEPHONE, 03 MAY 2023 BY TELEPHONE AND 04 MAY 2023 BY TELEPHONE AND EMAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1159653 | PELORIS II TISSUE PROCESSOR | AUTOMATED TISSUE PROCESSOR | IEO | LEICA BIOSYSTEMS MELBOURNE PTY. LTD | PELORIS II |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |