BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3131504 · Received May 10, 2013

    Report

    Report Number
    8020030-2013-00035
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 28, 2013
    Report Date
    April 15, 2013
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTTLE 5 (ETHANOL) MOVED OUT OF CONTACT WITH THE CORRESPONDING SENSOR FOR 4 SEC DURING THE REAGENT DRAIN PROCESS AT 18:36 PM ON (B)(6) 2013. WHEN CONTACT WITH THE SENSOR WAS RE-ESTABLISHED, THE <INSERTED BOTTLE CONFIGURATION> DIALOG BOX WOULD HAVE BEEN DISPLAYED ON THE INSTRUMENT MONITOR. A USER INCORRECTLY SELECTED THE <CHANGED> RADIO BUTTON FROM THE <INSERTED BOTTLE CONFIGURATION> DIALOG BOX DISPLAYED, WHICH RESET THE STATION PROPERTIES TO THE DEFAULT VALUE OF 100% FOR BOTTLE 5. HOWEVER, THE ACTUAL ETHANOL CONCENTRATION REMAINED AS 72.4% BECAUSE THE REAGENT HAD NOT BEEN REPLACED. RE-SETTING A REAGENT STATION SETS THE CONC TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS, UNLESS AN ALTERNATIVE VALUE IS ENTERED BY THE USER AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. BOTTLE 5 WAS USED FOR THE FIRST TIME IN THE FINAL DEHYDRATION STEP IN THE PROTOCOL IN THE AFFECTED PROTOCOL, BECAUSE THE INSTRUMENT SOFTWARE USES REAGENT CONC TO SELECT REAGENT STATIONS WHEN EXECUTING A PROTOCOL. THE REAGENT WITH THE HIGHEST CONC IS ALWAYS USED BEFORE CHANGING TO ANOTHER REAGENT GROUP OR TYPE. THE MINIMUM FINAL REAGENT CONC REQUIRED FOR ETHANOL IS 98%. USING ETHANOL AT A CONC LESS THAN THE MIN REQUIRED FOR THE FINAL DEHYDRATION STEP IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS; AND CONTAMINATION OF REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS, ULTIMATELY REPULSING IN SUB-OPTIMAL TISSUE PROCESSING REPORTED. THE ROOT CAUSE WAS A USE ERROR INVOLVING FAILURE TO FOLLOW INSTRUCTIONS DETAILED IN THE LEICA PELORIS II USER MANUAL, DETAILING THE OPTIONS TO BE USED WHEN THE <INSERTED BOTTLE CONFIGURATION> DIALOG BOX IS DISPLAYED.

    Description of Event or Problem · 1

    AS PART OF THE PREPARATION FOR CONDUCT OF SCHEDULED PREVENTATIVE MAINTENANCE, A LEICA FIELD SERVICE ENGINEER (FSE) REVIEWED INSTRUMENT LOGS SENT BY THE LABORATORY FOR THIS PURPOSE. THE FSE NOTED THAT AN ERROR CODE RECORDED IN THESE LOGS INDICATED THAT A REAGENT BOTTLE HAD BEEN REMOVED FROM THE INSTRUMENT FOR LESS THAN THE MINIMUM TIME REQUIRED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT. THE FSE RAISED THIS FINDING WITH THE LABORATORY. THE LABORATORY ADVISED THAT TISSUE SAMPLES IN THE PROCESSING RUN WHICH FOLLOWED HAD BEEN ADVERSELY AFFECTED; THAT THE AFFECTED SAMPLES WERE SUBSEQUENTLY RE-PROCESSED USING THE CLEANING CYCLE AND THE INCIDENT WAS NOT REPORTED TO LEICA BIOSYSTEMS. ON (B)(6) 2013, 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
    209481 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1