BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2934114 · Received January 4, 2013

    Report

    Report Number
    8020030-2013-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A USER REMOVED BOTTLE 3 (ETHANOL) FROM THE INSTRUMENT FOR 17 SECONDS AT 13:33PM ON (B)(4) 2012, WHICH IS NOT SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THIS REAGENT, IN RESPONSE TO INFO DISPLAYED IN ASSOCIATION WITH AN ERROR CODE INDICATING THAT A PROTOCOL COULD NOT BE RUN BECAUSE THE PROPERTIES OF ETHANOL IN THE REAGENT STATIONS 3-10 INCLUSIVE DID NOT MEET THE REQUIREMENTS FOR USE IN THE FINAL DEHYDRATION STEP. THE REAGENT STATION PROPERTIES WERE RESET AT 13:34PM ON (B)(4) 2012, WHICH SET 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 RESET 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 3 PRIOR TO THIS USER ACTION WERE: ETHANOL CONC. =52.7%, CYCLES=171, CASSETTES PROCESSED=7205 AND DAYS=94. BOTTLE 3 WAS THEN USED IN THE FINAL DEHYDRATION STEP OF THE "OVERNIGHT ROUTINE" PROTOCOL STARTED IN RETORT B AT 13:35PM ON (B)(4) 2012. 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 STEPS; AND CONTAMINATION OF REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS, ULTIMATELY RESULTING IN SUB-OPTIMAL TISSUE PROCESSING. CONTINUED USE OF THE INSTRUMENT W/O REPLACING ALL REAGENTS BETWEEN (B)(4) 2012, WOULD HAVE RESULTED IN CONTAMINATION OF REAGENTS AND WAXES USED FOR THESE PROTOCOLS AND ADVERSELY IMPACTED THE QUALITY OF TISSUE PROCESSING.

    Description of Event or Problem · 1

    LEICA MICROSYSTEMS REC'D A COMPLAINT REGARDING THE UNEXPECTED PRESENCE OF WAX IN A REAGENT BOTTLE. WHEN NOTIFYING LEICA MICROSYSTEMS OF THIS COMPLAINT, THE COMPLAINANT INDICATED THAT THE QUALITY OF TISSUE PROCESSING HAD NOT BEEN ADVERSELY AFFECTED. HOWEVER, THE COMPLAINANT SUBSEQUENTLY ADVISED THE LEICA FIELD SERVICE ENGINEER (FSE) WHO ATTENDED THE LABORATORY ON (B)(6) 2012 OF SUB-OPTIMAL TISSUE PROCESSING. THE TISSUE WAS DESCRIBED BY THE COMPLAINANT AS "SOGGY". ON (B)(6) 2012, LEICA MICROSYSTEMS REC'D INFO THAT A PATHOLOGIST REPORT WAS ISSUED FOR ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING. THE FOLLOWING COMMENT WAS ADDED TO THE REPORT OF FOUR (4) CASES: "LIMITED HISTOLOGY EVAL. MECHANICAL ERROR IN TISSUE PROCESSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5701 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1