BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6137378 · Received December 1, 2016

    Report

    Report Number
    8020030-2016-00086
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 2, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT FOUND THAT A USE ERROR OCCURRED AT 16:40PM ON (B)(6) 2016, WHEN A USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION IN BOTTLE 8 (ABSOLUTE ETHANOL) WAS TO BE SET TO DEFAULT VALUE OF 100%. THE ACTUAL ETHANOL CONCENTRATION IN BOTTLE 8 (ABSOLUTE ETHANOL) REMAINED UNCHANGED AT 80.2%, BECAUSE BOTTLE 8 (ABSOLUTE ETHANOL) HAD NOT BEEN 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. AS A CONSEQUENCE, BOTTLE 8 (ABSOLUTE ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP OF BOTH THE "SKIN/GI BXS" PROTOCOL STARTED IN RETORT A AT 16:46PM ON (B)(6) 2016 AND THE "ROUTINE 6HR" PROTOCOL STARTED IN RETORT B AT 16:47PM 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. THE TISSUE SAMPLES FROM THE "SKIN/GI BXS" PROTOCOL STARTED IN RETORT A AT 16:46PM ON (B)(6) 2016 AND THE "ROUTINE 6HR" PROTOCOL STARTED IN RETORT B AT 16:47PM ON (B)(6) 2016 WOULD HAVE BEEN FURTHER ADVERSELY IMPACTED BY THE REPORTED USE OF THE CLEANING PROTOCOL AS THE FIRST STEP IN THE REGIMEN USED TO RE-PROCESS THESE SAMPLES. USE OF THE CLEANING PROTOCOL TO RE-PROCESS SAMPLES IS A USE ERROR AS DETAILED IN SECTION 3.2 OF THE LEICA PELORIS/PELORIS LL USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARNING: "DO NOT USE CLEANING PROTOCOLS FOR REPROCESSING AS THE DRY STEP WILL DAMAGE TISSUE." THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED FROM BOTH THE "BX AND LARGE RUNS" PROTOCOLS EXECUTED ON (B)(6) 2016 WAS A USE ERROR. SPECIFICALLY, A USER FAILED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 8 (ABSOLUTE ETHANOL) IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS LL USER MANUAL. THE LEICA PELORIS/PELORIS LL USER MANUAL 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 TISSUE SAMPLES WOULD HAVE BEEN FURTHER ADVERSELY IMPACTED BY THE REPORTED USE OF THE CLEANING PROTOCOL AS THE FIRST STEP IN THE REGIMEN USED FOR RE-PROCESSING OF THE AFFECTED SAMPLES. USE OF THE CLEANING PROTOCOL TO RE-PROCESS SAMPLES IS ALSO A USE ERROR AS DETAILED IN SECTION 3.2 OF THE LEICA PELORIS/PELORIS LL USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARNING: "DO NOT USE CLEANING PROTOCOLS FOR REPROCESSING AS THE DRY STEP WILL DAMAGE TISSUE." THE ROOT CAUSE OF THE SUB-OPTIMAL PROCESSING REPORTED FROM A PROCESSING RUN(S) EXECUTED ON BOTH (B)(6) 2016 COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT TISSUE FROM A PROTOCOL RUN IN RETORT B ON THE EVENING OF (B)(6) 2016 WAS "NOT PROCESSING" AND "PATHOLOGIST SAYS ALCOHOL IN XYLENE." THE COMPLAINANT ALSO ADVISED THAT THE REAGENT IN BOTTLES 3, 6, 7 AND 8 HAD BEEN CHANGED; "XYLENES LOOK GOOD" AND "WAXES WERE NOT CHECKED." ON (B)(6) 2016, A LEICA FIELD SUPPORT SPECIALIST (FSS) ATTENDED THE LABORATORY IN ORDER TO OBTAIN FURTHER DETAILS OF THE CIRCUMSTANCES INVOLVED IN THE COMPLAINT AND TO PROVIDE APPLICATIONS SUPPORT. THE COMPLAINANT ADVISED THE FSS THAT: "THE FIRST PROBLEM WITH PROCESSING OCCURRED ON (B)(6) 2016 ON BOTH THE BX AND LARGE RUNS. THE TISSUE CAME OFF BOTH OF THESE TISSUE RUNS SEEMED RAW AND NOT PROCESSED." THE COMPLAINANT ALSO ADVISED THAT THE AFFECTED TISSUE SAMPLES FROM THESE PROTOCOLS HAD BEEN RE-PROCESSED BY "FIRST RUNNING TISSUE THROUGH THE CLEANING CYCLE AND THEN RE-RUNNING THE TISSUE PROGRAM." THE COMPLAINANT REPORTED THAT THE FOLLOWING SAMPLES FROM THE "SKIN/GI BXS" PROTOCOL STARTED IN RETORT A AT 16:46PM ON (B)(6) 2016 AND/OR THE "ROUTINE 6HR" PROTOCOL STARTED IN RETORT B AT 16:47PM ON (B)(6) 2016 WERE UNDIAGNOSABLE: LIVER BIOPSY SAMPLES DERIVED FROM THREE (3) MALE PATIENTS AND ONE (1) FEMALE PATIENT AND ONE (1) PROSTATE BIOPSY SAMPLE. THE FSS ALSO DOCUMENTED THAT RE-BIOPSY HAD BEEN RECOMMENDED FOR THE PATIENTS FOR WHOM TISSUE WAS UNDIAGNOSABLE. THE COMPLAINANT ALSO REPORTED THAT INTERMITTENT PROCESSING ISSUES, WHICH WERE DESCRIBED BY THE PATHOLOGISTS AS AN ARTEFACT CAUSED BY "ALCOHOL IN THE XYLENE ON THE TISSUE PROCESSOR", HAD BEEN SPECIFICALLY REPORTED BY THE PATHOLOGISTS ON BOTH (B)(6) 2016. ON (B)(6) 2016, THE FSS CONFIRMED THAT NO FURTHER INFORMATION WOULD BE PROVIDED REGARDING THE FIVE (5) PATIENTS FOR WHOM RE-BIOPSY WAS RECOMMENDED. AS A CONSEQUENCE, NEITHER AN IDENTIFIER NOR THE AGE/DATE OF BIRTH IS AVAILABLE FOR THE FIVE (5) PATIENTS FOR WHOM RE-BIOPSY WAS RECOMMENDED. REFER TO MFR. REPORT #8020030-2016-00083; 8020030-2016-00084; 8020030-2016-00085; AND #8020030-2016-00087 FOR THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790434 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention