BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 4180752 · Received October 8, 2014

    Report

    Report Number
    8020030-2014-00049
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTTLE 7 (ETHANOL) WAS REMOVED FROM THE INSTRUMENT FOR APPROXIMATELY THREE (3) MINUTES AT 08:42AM ON (B)(4) 2014, WHICH IS SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT, AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET. RESETTING THE REAGENT STATION SET THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS (100% I THIS INSTANCE); AND RESET THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. HOWEVER, THE ETHANOL CONCENTRATION MEASURED BY THE LABORATORY SUBSEQUENT TO THIS ACTION WAS 85%, WHICH INDICATES THAT AN ERROR OCCURRED DURING THE REPLACEMENT OF REAGENT IN BOTTLE 7 (ETHANOL). BOTTLE 7 (ETHANOL) WS THEN USED FOR THE FINAL DEHYDRATION STEP OF THE TWO (2) PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. 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 SUBSEQUENT PROCESSING STEPS ULTIMATELY RESULTING IN SUB-OPTIMAL PROCESSING. THE ROOT CAUSE FOR THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED DURING THE REPLACEMENT OF ETHANOL IN BOTTLE 7 AND COMPLETED PRIOR TO COMMENCEMENT OF THE TWO (2) PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL TISSUE PROCESSING OF APPROXIMATELY 30 BIOPSIES, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). PRELIMINARY INFORMATION PROVIDED BY THE LABORATORY INDICATED THAT A USER HAD REPLACED THE REAGENT IN BOTTLE 7 ON (B)(4) 2014; AND THE ETHANOL CONCENTRATION IN THIS BOTTLE WAS 85% WHEN MEASURED BY THE LABORATORY. ON (B)(4) 2014, 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
    632863 PELORIS RAPID TISSUE PROCESSOR AUTOMATIC TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1