BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 4180772 · Received October 8, 2014

    Report

    Report Number
    8020030-2014-00048
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 11, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE INSTRUMENT LOGS FOUND THAT BOTTLE (B)(6) (ETHANOL) WAS REMOVED FROM THE INSTRUMENT SOFTWARE FOR 9 SECONDS AT 09:13AM ON (B)(6) 2014 IN RESPONSE TO INFORMATION DISPLAYED IN ASSOCIATED WITH AN ERROR CODE. THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET, WHICH SET THE CONCENTRATION TO THE DEFAULT VALUE OF (B)(6) 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 (B)(6) REMAINED UNCHANGED AT (B)(6) BECAUSE THE REAGENT HAD NOT BEEN REPLACED. BOTTLE (B)(6) (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP OF THE (B)(6) PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE MINIMUM FINAL REAGENT CONCENTRATION FOR ETHANOL IS (B)(6). THE CONSEQUENCES OF USING ETHANOL AT 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 AFFECTED PROTOCOLS. SPECIFICALLY, THE USER FAILED TO COMPLETE THE MANUAL REAGENT REPLACEMENT PROCESS IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE (B)(6) PELORIS/PELORIS (B)(6) USER MANUAL.

    Description of Event or Problem · 1

    DURING A SITE VISIT ON (B)(6) 2014, A (B)(6) SALES ACCOUNT EXECUTIVE (SAE) WAS ADVISED THAT PROCESSING RUN(S) COMPLETED ON (B)(6) 2014, SHOWED SIGNS OF WATER IN THE TISSUE. PRELIMINARY INFORMATION PROVIDED TO THE SAE INDICATES THAT A USER EITHER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF (B)(6) WAS TO BE SET WHEN THE REAGENT IN THE BOTTLE INVOLVED WAS ACTUALLY (B)(6); OR A USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF (B)(6) WAS TO BE SET WITHOUT REPLACING THE REAGENT IN THE REAGENT BOTTLE. THE COMPLAINANT ALSO ADVISED THAT THE QUALITY OF TISSUE PROCESSING WAS SATISFACTORY FOLLOWING THE REPLACEMENT OF ALL REAGENTS; AND ALL THE TISSUE SAMPLES INVOLVED WERE DIAGNOSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633039 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1