BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6184684 · Received December 19, 2016

    Report

    Report Number
    8020030-2016-00088
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 19, 2016
    Report Date
    November 22, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CODE RECORDED IN THE INSTRUMENT LOGS AT 13:49PM ON (B)(6) 2016 INDICATES THAT BOTTLE 6 (ETHANOL) WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 19 SECONDS, WHICH IS NOT SUFFICIENT TIME TO REPLACE THE REAGENT; AND THE PROPERTIES OF REAGENT STATION WERE RESET. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION IN BOTTLE 6 (ETHANOL) WAS TO BE SET TO 100% AT 13:49PM ON (B)(6) 2016, THE ACTUAL CONCENTRATION OF REAGENT IN BOTTLE 6 (ETHANOL) REMAINED UNCHANGED AT 81.3% BECAUSE THE BOTTLE 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 6 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP OF THE "1.5 HOUR" PROTOCOLS STARTED IN RETORT A AT 01:26AM ON (B)(6) 2016; IN RETORT B AT 03:25AM ON (B)(6) 2016 AND IN RETORT A AT 06:31AM ON (B)(6) 2016. 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/CLEARING 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. INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THE "1.5 HOUR" PROTOCOLS STARTED IN RETORT A AT 01:26AM ON (B)(6) 2016; IN RETORT B AT 03:25AM ON (B)(6) 2016 AND IN RETORT A AT 06:31AM ON (B)(6) 2016. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED AT 13:49PM ON (B)(6) 2016. SPECIFICALLY, A USER FAILED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 6 (ETHANOL) 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

    A LEICA BIOSYSTEMS FIELD SUPPORT SPECIALIST (FSS) WAS ADVISED THAT SAMPLES OF SKIN TISSUE WERE FOUND TO BE "HARD LIKE ROCK CANDY" FOLLOWING PROCESSING. THE COMPLAINANT ADVISED THE FSS THAT IT WAS BELIEVED THAT THE SUB-OPTIMAL TISSUE PROCESSING REPORTED MAY BE DUE TO HUMAN ERROR; ALL AFFECTED TISSUE SAMPLES HAD BEEN EMBEDDED, CUT AND STAINED; NO RE-PROCESSING OF THE AFFECTED TISSUE SAMPLES HAD BEEN UNDERTAKEN; MOST CASES WERE DIAGNOSABLE; 12 CASES REQUIRED ADDITIONAL LEVELS; THE REAGENT IN BOTTLE 14, WHICH WAS NOTICEABLY DIRTY, CONTAINED SMALL DROPLETS OF LIQUID AND SHOWED SLIGHT EOSIN CONTAMINATION AND THE CONTENTS OF ALL REAGENT BOTTLES HAD BEEN REPLACED SUBSEQUENT TO THE IDENTIFICATION OF SUB-OPTIMAL TISSUE PROCESSING. ON 01 DECEMBER 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ONE (1) CASE WAS NOT DIAGNOSABLE. IT WAS REPORTED THAT THE PATHOLOGIST HAD STATED THAT THE TISSUE WAS OF QUESTIONABLE QUALITY PRIOR TO PROCESSING, AND IT WAS UNKNOWN WHETHER THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT CONTRIBUTED TO THE RECOMMENDATION FOR RE-BIOPSY. IT WAS ALSO NOT KNOWN WHETHER THE RE-BIOPSY RECOMMENDED HAD BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837282 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention