BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3934673 · Received June 25, 2014

    Report

    Report Number
    8020030-2014-00021
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BOTTLE 11 (IPA) WAS REMOVED FROM THE INSTRUMENT FOR APPROXIMATELY FIVE (5) MINUTES AT 14:49PM OR (B)(6) 2014, WHICH IS SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT, AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET. RESETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS (100% IN THIS INSTANCE); AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. HOWEVER, THE VARIANCE BETWEEN THE IPA CONCENTRATION OF 88% MEASURED BY A LEICA FIELD SERVICE ENGINEER ON (B)(4) 2014 USING A HYDROMETER, AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE OF 100%, INDICATES AN ERROR OCCURRED DURING COMPLETION OF THIS ACTION. BOTTLE 11 WAS THEN USED FOR THE FINAL DEHYDRATION/CLEARING STEP OF THE "PORTSMOUTH - 15HR XYLENE FREE" PROTOCOL STARTED IN RETORT A, AT 16:15PM ON (B)(6) 2014. THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR IPA IS 95%. THE CONSEQUENCES OF USING IPA AT A CONCENTRATION LESS THAN THE MINIMUM REQUIRED FOR THE FINAL DEHYDRATION/CLEARING STEP IN A PROTOCOL IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS; AND CONTAMINATION OF REAGENTS USED IN SUBSEQUENT PROCESSING STEPS ULTIMATELY RESULTING IN SUB-OPTIMAL PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED DURING THE REPLACEMENT OF IPA IN BOTTLE 11 AND COMPLETED PRIOR TO COMMENCEMENT OF THE "PORTSMOUTH - 15HR XYLENE FREE" PROTOCOL.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A 15HR XYLENE FREE PROTOCOL, WHICH COMPLETED ON (B)(6) 2014, USING PELORIS II TISSUE PROCESSOR. THE LABORATORY ADVISED THAT THE CENTRE AREA OF THE TISSUE SAMPLES WERE NOTED TO BE UNDER-PROCESSED, WHICH ALSO HAS A "CRISPY" APPEARANCE FROM THE OUTSIDE. A LEICA FIELD SUPPORT SPECIALIST (FSS) ATTENDED THE LABORATORY ON (B)(4) 2014 AND MEASURED THE CONCENTRATION OF THE REAGENT BOTTLES. THE MEASURED CONCENTRATION FOR BOTTLE 11 (IPA) WAS 88% AND THE CORRESPONDING CALCULATED CONCENTRATION WAS 100%. ON (B)(6) 2014, LEICA BIOSYSTEMS RECEIVED INFORMATION FROM THE LABORATORY INDICATING RE-BIOPSY OF NINE (9) PATIENTS AND DECISION REGARDING FOLLOW-UP OF ANOTHER NINE (9) PATIENTS WAS TO BE MADE BY THE TREATING CLINICIAN(S). REFER TO MFR. REPORT# 8020030-2014-00022, 8020030-2014-00023, 8020030-2014-00024, 8020030-2014-00025, 8020030-2014-00026, 8020030-2014-00027, 8020030-2014-00028, 8020030-2014-00029 AND 8020030-2014-00030 FOR SPECIFIC DETAILS OF THE AFFECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371201 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention