BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3130176 · Received May 21, 2013

    Report

    Report Number
    8020030-2013-00040
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A USER REMOVED BOTTLE 11 (IPA) FROM THE INSTRUMENT FROM APPROX. THREE (3) SECONDS AT 17:12PM ON (B)(4) 2013, WHICH IS INSUFFICIENT TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT. THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE THEN RESET. RESETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS UNLESS A USER ENTERS AN ALTERNATIVE VALUE INTO THE INSTRUMENT SOFTWARE; AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF 100% WAS TO BE SET FOR BOTTLE 11 (IPA), THE ACTUAL ALCOHOL CONCENTRATION REMAINED AS 93.3% BECAUSE THE REAGENT HAD NOT BEEN REPLACED. THE INSTRUMENT SOFTWARE USES REAGENT CONCENTRATION TO SCHEDULE REAGENT STATIONS WHEN SCHEDULING A PROTOCOL, AND THE REAGENT WITH THE HIGHEST CONCENTRATION IS ALWAYS USED FOR THE LAST STEP BEFORE CHANGING TO ANOTHER REAGENT GROUP OR TYPE. AS A CONSEQUENCE, THE REAGENT IN BOTTLE 11 WAS USED FOR THE DEHYDRATION/CLEARING STEP IN THE PROTOCOL EXHIBITING SUB-OPTIMAL TISSUE PROCESSING. THE REQUIRED MINIMUM FINAL REAGENT CONCENTRATION FOR IPA IS 95%. USING ALCOHOL AT LESS THAN THE MINIMUM REQUIRED FOR THE FINAL PROCESSING STEP PRIOR TO THE WAX INFILTRATION STEPS IN A PROTOCOL ARE RE-INTRODUCTION OF WATER INTO THE TISSUE, WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS: AND CONTAMINATION OF REAGENTS USED FOR SUBSEQUENT PROCESSING. THE ROOT CAUSE FOR THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED DURING THE REPLACEMENT OF IPA IN BOTTLE 11 COMPLETED PRIOR TO COMMENCEMENT OF THE AFFECTED RUN.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUBOPTIMAL TISSUE PROCESSING IDENTIFIED FROM ONE (1) PROTOCOL, USING PELORIS 11 TISSUE PROCESSOR. THE AFFECTED TISSUE SAMPLES WERE DESCRIBED BY THE COMPLAINANT AS DRY AND BRITTLE. 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 FOUND THAT ON (B)(4) 2013, WHICH WAS IMMEDIATELY PRIOR TO COMMENCEMENT OF THE PROCESSING RUN FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED, THE LAB SUPERVISOR HAD RESET THE PROPERTIES OF THE REAGENT STATION FOR BOTTLE 11 (IPA) WITHOUT REPLACING THE REAGENT. ON (B)(4) 2013, LEICA BIOSYSTEMS RECEIVED INFO THAT TISSUE SAMPLES FROM SEVERAL PATIENTS WERE NOT DIAGNOSABLE. CLARIFICATION REGARDING THE NUMBER OF PATIENTS INVOLVED AND INFO AS TO WHETHER RE-BIOPSY OF ANY PT(S) HAS BEEN CONDUCTED HAS BEEN REQUESTED FROM THE LAB. AS OF (B)(4) 2013, THE INFO REQUESTED HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225382 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS 11

    Patients

    Seq Age Sex Outcome Treatment
    1