BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3190773 · Received June 20, 2013

    Report

    Report Number
    8020030-2013-00043
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS SHOW THAT BOTTLE 7 (ETHANOL) WAS REMOVED FROM THE INSTRUMENT FOR 6 SECONDS, WHICH IS NOT SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THIS REAGENT, AND THE CORRESPONDING REAGENT STATION WAS RESET AT 22:12 PM ON (B)(6) 2013. RE-SETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS, 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. THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE ETHANOL CONCENTRATION WAS TO BE SET TO 100% IN THIS INSTANCE. THE PROPERTIES OF THE REAGENT IN BOTTLE 7 PRIOR TO THIS USER ACTION WERE: ETHANOL CONC. = 55.7%, CYCLES = 83, CASSETTES PROCESSED = 8949 AND DAYS = 78. AS THE REAGENT WAS NOT PHYSICALLY REPLACED, THE ETHANOL CONCENTRATION REMAINED AS 55%. BOTTLE 7 WAS USED FOR THE FINAL DEHYDRATION STEP OF THE PROTOCOL FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED, BECAUSE THE INSTRUMENT SOFTWARE USES REAGENT CONCENTRATION TO SELECT REAGENT STATIONS WHEN EXECUTING A PROTOCOL. THE REQUIRED MINIMUM FINAL REAGENT CONCENTRATION FOR ETHANOL IS 98%. THE CONSEQUENCES OF USING ETHANOL AT LESS THAN THE MINIMUM FINAL CONCENTRATION ARE RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS AND CONTAMINATION OF REAGENTS USED FOR SUBSEQUENT PROCESSING STEPS, ULTIMATELY RESULTING IN THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. THE ROOT CAUSE FOR THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A FAILURE BY THE USER TO COMPLETE THE MANUAL REAGENT REPLACEMENT PROCESS IN ACCORDANCE WITH THE MFR INSTRUCTIONS IN THE LEICA PELORIS/PELORIS 11 USER MANUAL PRIOR TO COMMENCEMENT OF THE AFFECTED PROTOCOL.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE IN APPROXIMATELY 27 BLOCKS, WHICH REQUIRED SUBSEQUENT RE-PROCESSING, USING PELORIS 11 TISSUE PROCESSOR. A LEICA FIELD SUPPORT SPECIALIST (FSS) ATTENDED THE LABORATORY ON (B)(4) 2013, IN ORDER TO INVESTIGATE THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT AND TO PROVIDE APPLICATIONS SUPPORT. THE FSS REVIEWED THE INSTRUMENT LOG AND NOTED THAT A REAGENT BOTTLE HAD BEEN REMOVED FROM THE INSTRUMENT FOR LESS THAN TWO (2) MINUTES AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION RESET. ON (B)(4) 2013, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL TISSUE PROCESSING WERE DIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281001 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1