BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 4152237 · Received October 3, 2014

    Report

    Report Number
    8020030-2014-00046
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 11, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INSTRUMENT LOGS FOUND THAT BOTTLE 7 (ETHANOL) WAS REMOVED FROM THE INSTRUMENT FOR 12 SECONDS AT 20:35PM ON (B)(6) 2014. THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET, WHICH SET THE CONCENTRATION TO THE DEFAULT VALUE OF 100% CONFIGURED IN THE REAGENT TYPES DEFINITIONS, AND RESET THE NUMBER OF CASSETTES AND THE NUMBER OF CYCLES AND DAYS TO ZERO. HOWEVER, AS THIS PERIOD IS INSUFFICIENT TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT, THE ACTUAL CONCENTRATION OF THE ETHANOL IN BOTTLE 7 REMAINED UNCHANGED AT 85.8% BECAUSE THE REAGENT HAD NOT BEEN REPLACED. BOTTLE 7 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP OF THE TWO (2) PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE MINIMUM FINAL REAGENT CONCENTRATION 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 THE REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS ULTIMATELY RESULTING IN SUB-OPTIMAL TISSUE PROCESSING. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED PRIOR TO COMMENCEMENT OF THE TWO (2) AFFECTED PROTOCOLS. SPECIFICALLY, THE USER FAILED TO COMPLETE THE MANUAL REAGENT REPLACEMENT PROCESS IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS 11 USER MANUAL.

    Description of Event or Problem · 1

    DURING A CUSTOMER CARE LABORATORY VISIT, A LEICA BIOSYSTEMS PRODUCT APPLICATIONS SPECIALIST (PAS) RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE FROM BOTH A 12 HR. AND 1 HR. PROTOCOL COMPRISING 90 AND 28 CASSETTES RESPECTIVELY. THE COMPLAINANT ADVISED THAT THE AFFECTED TISSUE SAMPLES, WHICH WERE DESCRIBED AS UNDER-PROCESSED, HAD BEEN RE-PROCESSED USING ANOTHER PELORIS TISSUE PROCESSOR AND WERE DIAGNOSABLE. THE PAS REVIEWED THE INSTRUMENT LOGS IN ORDER TO INVESTIGATE THE CIRCUMSTANCED INVOLVED IN THIS COMPLAINT AND NOTED AN ERROR CODE INDICATING THAT BOTTLE 7 (ETHANOL) HAD BEEN REMOVED FROM THE INSTRUMENT FOR LESS THAN THE MINIMUM TIME REQUIRED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT, AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION HAD BEEN RESET. THE LOGS ALSO SHOWED THAT SUBSEQUENT TO THIS INCORRECT USER ACTION, BOTTLE 7 WAS USED FOR THE FINAL DEHYDRATION STEP IN BOTH A 12 HOUR AND 1 HOUR PROCESSING RUN. THE PAS WAS UNABLE TO MEASURE THE ETHANOL CONCENTRATION IN THE BOTTLES DESIGNATED FOR ETHANOL BECAUSE ALL THE REAGENTS ON THE INSTRUMENT AT THE TIME OF THE EVENT HAD BEEN DISCARDED AND REPLACED FOLLOWING THE IDENTIFICATION OF SUB-OPTIMAL TISSUE PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617240 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1