PELORIS RAPID TISSUE PROCESSOR
Report
- Report Number
- 8020030-2020-00065
- Event Type
- Injury
- Date Received
- December 15, 2020
- Date of Event
- November 17, 2020
- Report Date
- December 23, 2020
- 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
"THE AVAILABLE INFORMATION AND DATA DO NOT MEET REGULATORY AGENCY REPORTABILITY CRITERIA BECAUSE THERE IS NO INFORMATION THAT REASONABLY SUGGESTS THAT THERE WAS A REPORTED INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT; AND IF THERE IS INFORMATION THAT REASONABLY SUGGESTS THAT THERE WAS A DEVICE MALFUNCTION, IT IS NOT LIKELY THAT THE MALFUNCTION WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY UPON RECURRENCE."
MANUFACTURER EVALUATION OF THE INSTRUMENT LOGS SHOWED THAT: BOTTLE 5 [IMS (IDA)] WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 16 SECONDS AT 15:57PM ON (B)(6) 2020, WHICH IS NOT SUFFICIENT TIME TO REPLACE THE REAGENT; AND THE STATION PROPERTIES WERE RESET AT 15:57PM ON (B)(6) 2020, WITH A USER AFFIRMING IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION WAS TO BE SET TO THE DEFAULT VALUE OF 100%. THE PROPERTIES OF THE REAGENT IN BOTTLE 5 PRIOR TO THESE USER ACTIONS WERE: IMS (IDA) CONCENTRATION=98.1%, CYCLE=24, CASSETTES= 1108 AND DAYS=155. BOTTLE 6 [IMS (IDA)] WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 16 SECONDS AT 15:57PM ON (B)(6) 2020, WHICH IS NOT SUFFICIENT TIME TO REPLACE THE REAGENT; AND THE STATION PROPERTIES WERE RESET AT 15:57PM ON (B)(6) 2020, WITH A USER AFFIRMING IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION WAS TO BE SET TO THE DEFAULT VALUE OF 100%. THE PROPERTIES OF THE REAGENT IN BOTTLE 6 PRIOR TO THESE USER ACTIONS WERE: IMS (IDA) CONCENTRATION=96.5%, CYCLE=27, CASSETTES= 1373 AND DAYS=50. BOTTLE 8 [IMS (IDA)] WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 0 SECONDS 15:57PM ON (B)(6) 2020; AND THE STATION PROPERTIES WERE RESET AT 15:57PM ON (B)(6) 2020, WITH A USER AFFIRMING IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION WAS TO BE SET TO THE DEFAULT VALUE OF 100%. THE PROPERTIES OF THE REAGENT IN BOTTLE 8 PRIOR TO THESE USER ACTIONS WERE: IMS (IDA) CONCENTRATION=85.0%, CYCLE=34, CASSETTES= 1597 AND DAYS=76. BOTTLES 9 [IMS (IDA)] AND 10 [IMS (IDA)] WERE EACH NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR SUFFICIENT TIME TO REPLACE THE REAGENT; AND THE STATION PROPERTIES WERE RESET AT 15:58PM ON (B)(6) 2020, WITH A USER AFFIRMING IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION WAS TO BE SET TO THE DEFAULT VALUE OF 100%. THE PROPERTIES OF THE REAGENT IN BOTTLE 9 PRIOR TO THESE USER ACTIONS WERE: IMS (IDA) CONCENTRATION=98.7%, CYCLE=19, CASSETTES= 774 AND DAYS=163. THE PROPERTIES OF THE REAGENT IN BOTTLE 10 PRIOR TO THESE USER ACTIONS WERE: IMS (IDA) CONCENTRATION=99.2%, CYCLE=12, CASSETTES= 456 AND DAYS=29. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE ETHANOL CONCENTRATION IN BOTTLE 8 [IMS (IDA)] WAS TO BE SET TO THE DEFAULT VALUE OF 100% AT 15:57PM ON (B)(6) 2020, THE ACTUAL [IMS (IDA)] CONCENTRATION WOULD HAVE REMAINED UNCHANGED AT 85.0%, BECAUSE THE BOTTLE WAS NOT REMOVED FROM THE INSTRUMENT FOR SUFFICIENT TIME TO REPLACE THE REAGENT. 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. FOLLOWING THE USE ERROR WHEN REPLACING THE REAGENT IN BOTTLE 8 (IMS (IDA)) AT 15:57PM ON (B)(6) 2020, THE CONTENTS OF THIS BOTTLE WERE USED FOR THE FINAL DEHYDRATION STEP OF THE "RAPID [3 HOURS XYLENE]" PROTOCOL STARTED IN RETORT A AT 10:35AM ON (B)(6) 2020; AND THE "ROUTINE [XYLENE]" PROTOCOL STARTED IN RETORT B AT 17:15PM ON (B)(6) 2020, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. ALTHOUGH NOT REPORTED BY THE COMPLAINANT, THE QUALITY OF TISSUE PROCESSING FROM THE "ROUTINE [XYLENE]" PROTOCOL STARTED IN RETORT A AT 19:51PM ON (B)(6) 2020 WOULD ALSO HAVE BEEN ADVERSELY IMPACTED BECAUSE THE REAGENT FROM BOTTLE 8 [IMS (IDA)] WAS ALSO USED FOR THE FINAL DEHYDRATION STEP IN THIS PROTOCOL. THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR THE FINAL DEHYDRATION STEP 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 STEP, 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 FUNCTIONED AS DESIGNED DURING EXECUTION OF BOTH THE "RAPID [3 HOURS XYLENE]" PROTOCOL STARTED IN RETORT A AT 10:35AM ON (B)(6) 2020 AND THE "ROUTINE [XYLENE]" PROTOCOL STARTED IN RETORT B AT 17:15PM ON (B)(6) 2020, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT WAS THE USE ERROR, WHICH OCCURRED AT 15:57PM ON (B)(6) 2020, WHEN THE REAGENT CONCENTRATION IN BOTTLE 8 [IMS (IDA)] WAS RESET TO THE DEFAULT VALUE OF 100% WITHOUT REPLACING THE REAGENT IN THE BOTTLE. CONSEQUENTLY, THE IMS CONCENTRATION IN BOTTLE 8 REMAINED AS 84.0%, WHICH IS BELOW THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR THE FINAL DEHYDRATION STEP IN A PROTOCOL OF 98%, RESULTING IN THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT WHEN USED FOR THE FINAL DEHYDRATION STEP IN THE "RAPID [3 HOURS XYLENE]" PROTOCOL STARTED IN RETORT A AT 10:35AM ON (B)(6) 2020; AND THE "ROUTINE [XYLENE]" PROTOCOL STARTED IN RETORT B AT 17:15PM ON (B)(6) 2020. ALTHOUGH NOT REPORTED BY THE COMPLAINANT, THE QUALITY OF TISSUE PROCESSING FROM THE "ROUTINE [XYLENE]" PROTOCOL STARTED IN RETORT A AT 19:51PM ON (B)(6) 2020 WOULD ALSO HAVE BEEN ADVERSELY IMPACTED BECAUSE THE REAGENT FROM BOTTLE 8 [IMS (IDA)] WAS ALSO USED FOR THE FINAL DEHYDRATION STEP IN THIS PROTOCOL. THE FACTS INDICATE THAT MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 8 [IMS (IDA)] 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."
THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS AND REPORTED THAT TISSUE SAMPLES, WHICH HAD BEEN PROCESSED USING PELORIS RAPID TISSUE PROCESSOR SERIAL NUMBER (B)(4), WERE "DRY AND BRITTLE". ON (B)(6) 2020, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING FURTHER INFORMATION, WHICH WAS REPORTED BY THE COMPLAINANT,FROM THE LOCAL TAC HELPDESK ENGINEER-PATHOLOGY IN RELATION TO THE EVENT: "CUSTOMER CALLED IN THIS MORNING ADVISING THAT THE INSTRUMENT COMPLETED THE OVERNIGHT RUN BUT THE TISSUE IS DRY AND BRITTLE. THEY ONLY HAD 30 SURGICAL SPECIMENS AND 29 POST MORTEM SPECIMENS IN RETORT B ON THIS RUN. THEY ALSO NOTICED THAT THEY YESTERDAYS AFTERNOONS RUN IN RETORT A WHICH HAD 13 SAMPLES IN RETORT A HAD AN ISSUE AS WELL. THEY HAVE TRIED TO REPLACE THE REAGENTS AND THE WAXES AND THEY TOLD ME THAT WAX CHAMBER 4 IS SAYING THAT IT IS EMPTY BUT THERE IS STILL WAX IN IT SO COULD BE A BLOCKAGE SOMEWHERE." ON (B)(6) 2020, THE LOCAL TAC HELPDESK ENGINEER-PATHOLOGY RECEIVED THE FOLLOWING INFORMATION FROM THE SENIOR SPECIALIST BIOMEDICAL SCIENTIST & QUALITY LEAD BY EMAIL: "NONE OF THE BLOCK WERE REPROCESSED ALTHOUGH SUB-OPTIMAL I BELIEVE A DIAGNOSIS WAS MADE. ONE OF THE CASE IS STILL UNDER INVESTIGATION SO I CANNOT COMMENT FURTHER AT THIS STAGE." ON (B)(6) 2020, LEICA BIOSYSTEMS MELBOURNE RECEIVED THE FOLLOWING INFORMATION FROM THE SENIOR SPECIALIST BIOMEDICAL SCIENTIST & QUALITY LEAD BY EMAIL: "ALL SUBOPTIMAL BUT SIGNED OUT. ONE TUMOUR BX WAS NOT DIAGNOSABLE AND IMMUNE WAS NON-CONTRIBUTORY BUT WE CURRENTLY DON'T KNOW IF THIS WAS JUST BECAUSE OF THE LESION OR THE PROCESSING. CASE STILL UNDER INVESTIGATION." ON (B)(6) 2020, THE ASSIGNED LEICA FIELD SUPPORT SCIENTIST RECEIVED THE FOLLOWING INFORMATION FROM THE SENIOR SPECIALIST BIOMEDICAL SCIENTIST & QUALITY LEAD BY EMAIL: "AT I AM UNABLE TO COMMENT AT THIS STAGE AS THE PATIENT WAS ONLY RE-BIOPSY YESTERDAY. ON (B)(6) 2020, THE LOCAL LEICA TAC HELPDESK ENGINEER - PATHOLOGY REQUESTED THE FOLLOWING INFORMATION FROM THE LABORATORY BY EMAIL FOR THE PATIENT FOR WHOM RE-BIOPSY WAS PERFORMED: AN IDENTIFIER AND AGE/DOB AND GENDER. ON (B)(6) 2020, THE LOCAL LEICA TAC HELPDESK ENGINEER - PATHOLOGY RECEIVED THE FOLLOWING INFORMATION FROM THE LABORATORY MANAGER: "THE CASE IN QUESTION WAS EXTREMELY DIFFICULT TO DIAGNOSE AND IT WAS NOT KNOWN AT THE TIME IF THIS WAS DUE TO THE PROCESSING ERROR OR SOMETHING ELSE. HOWEVER, THE REPEAT BIOPSY, WHICH WAS PROCESSED APPROPRIATELY, PRESENTED THE PATHOLOGIST WITH EXACTLY SAME DIAGNOSTIC DIFFICULTY AND WAS THEREFORE JUDGED, TO BE DUE TO THE PATIENT'S SAMPLE AND DISEASE RATHER THAN POOR PROCESSING OF THE ORIGINAL BIOPSY ON THE PELORIS."THE AVAILABLE INFORMATION AND DATA DO NOT MEET REGULATORY AGENCY REPORTABILITY CRITERIA BECAUSE THERE IS NO INFORMATION THAT REASONABLY SUGGESTS THAT THERE WAS A REPORTED INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT; AND IF THERE IS INFORMATION THAT REASONABLY SUGGESTS THAT THERE WAS A DEVICE MALFUNCTION, IT IS NOT LIKELY THAT THE MALFUNCTION WOULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY UPON RECURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1475882 | PELORIS RAPID TISSUE PROCESSOR | AUTOMATED TISSUE PROCESSOR | IEO | LEICA BIOSYSTEMS MELBOURNE PTY. LTD | PELORIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |