BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS TISSUE PROCESSOR

    MDR report key: 6071697 · Received November 1, 2016

    Report

    Report Number
    8020030-2016-00051
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 2, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). A CODE RECORDED IN THE INSTRUMENT SOFTWARE AT 08:47AM ON (B)(6) 2016 INDICATES THAT BOTTLE 10 (ETHANOL) WAS REMOVED FROM THE INSTRUMENT FOR APPROXIMATELY 17 SECONDS, WHICH IS INSUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT; AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET. RESETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITION UNLESS AN ALTERNATIVE VALUE IS ENTERED INTO THE INSTRUMENT SOFTWARE BY THE USER; AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE REAGENT CONCENTRATION IN BOTTLE 10 (ETHANOL) WAS TO BE SET TO 100% AT 08:48AM ON (B)(6) 2016, THE ACTUAL CONCENTRATION OF THE REAGENT IN BOTTLE 10 (ETHANOL) UNCHANGED AT 97.3% BECAUSE THE REAGENT HAD NOT BEEN REPLACED. 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 OF TYPE IS SELECTED FOR THE FIRST STEP USING THAT REAGENT GROUP OR TYPE. 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. THE MINIMUM FINAL REAGENT CONCENTRATIONS 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. DUE TO THIS USE ERROR, THE REAGENT CONCENTRATION WAS LESS THAN 97.3% WHEN BOTTLE 10 (ETHANOL) WAS USED IN THE FINAL DEHYDRATION STEP OF THE "GI BX" PROTOCOL STARTED IN RETORT B AT 22:47PM ON (B)(6) 2016; THE "GI BX" PROTOCOL STARTED IN RETORT B AT 00:52AM ON (B)(6) 2016; AND THE "GI BX" PROTOCOL STARTED IN RETORT B AT 02:50AM ON (B)(6) 2016. INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF THE PROCESSING RUNS COMPLETED IN RETORT B ON (B)(6) 2016. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED AT 08:48AM ON (B)(6) 2016. SPECIFICALLY, A USER FAILED TO PERFORM MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 10 (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."

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OCCURRED ON (B)(6) 2016, USING RETORT B. THE LABORATORY DESCRIBED THE AFFECTED TISSUE SAMPLES AS "UNDERPROCESSED". ON 02 SEPTEMBER 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL TISSUE PROCESSING WERE DIAGNOSABLE. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722671 PELORIS TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1