BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3113613 · Received May 8, 2013

    Report

    Report Number
    8020030-2013-00031
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTTLES 3 (70% ETHANOL), 2 (70% ETHANOL), 5 (ETHANOL) AND 14 (XYLENE) WERE EACH REMOVED FROM THE INSTRUMENT FOR APPROXIMATELY TWO (2) MINUTES AT VARIOUS TIMES BETWEEN 09:27AM AND 09:34AM ON (B)(4) 2013. THIS IS SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN EACH CASE. THE PROPERTIES EACH 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. THE USER AFFIRMED THAT THE DEFAULT CONCENTRATION WAS TO BE SET FOR EACH REAGENT IN THIS CASE. THE DEFAULT CONCENTRATION IS 70% FOR BOTTLES 3 AND 4, AND 100% FOR BOTTLES 5 AND 14. ALTHOUGH THE USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF 100% WAS TO BE SET FOR BOTTLE 5 (ETHANOL), THE VARIANCE BETWEEN THE CONCENTRATION MEASURED USING A HYDROMETER (81%) AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE (100%) INDICATES THAT REPLACEMENT OF THIS REAGENT WAS NOT COMPLETED CORRECTLY. 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 5 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP IN THE RUNS EXHIBITING SUB-OPTIMAL TISSUE PROCESSING. THE REQUIRED MINIMUM FINAL REAGENT CONCENTRATION FOR ETHANOL IS 98%. USING ETHANOL AT LESS THAN THE MINIMUM CONCENTRATION REQUIRED RESULTS IN RE-INTRODUCTION OF WATER INTO THE TISSUE, WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS AND CONTAMINATION OF REAGENTS USED IN SUBSEQUENT STEPS.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS REC'D A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE IN APPROXIMATELY 30 BLOCKS, USING PELORIS 11 TISSUE PROCESSOR SERIAL NUMBER (B)(4). THE COMPLAINANT DESCRIBED THE AFFECTED TISSUE SAMPLES AS "MUSHY" AND TRANSPARENT. ON (B)(4) 2013, LEICA BIOSYSTEMS REC'D INFO FROM THE LABORATORY WHICH INDICATED THAT A PANCREATIC BIOPSY FROM EACH OF TWO (2) PTS WAS NOT DIAGNOSABLE. ON (B)(4) 2013, LEICA BIOSYSTEMS REC'D INFO FROM THE LABORATORY INDICATING THAT RE-BIOPSY OF ONE (1) PT ONLY WAS REQUIRED. AN IDENTIFIER AND THE AGE/DATE OF BIRTH AND SEX OF THE PT WERE NOT PROVIDED AT THIS TIME. THESE DETAILS HAVE BEEN SOUGHT FROM THE LABORATORY, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200054 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS 11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention