BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 4810488 · Received June 1, 2015

    Report

    Report Number
    8020030-2015-00045
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS TWO (2) USE ERRORS INVOLVING THE REPLACEMENT OF REAGENTS, WHICH OCCURRED PRIOR TO COMMENCEMENT OF THE TWO (2) AFFECTED PROTOCOLS. SPECIFICALLY, A USER FAILED TO FOLLOW THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS 11 USER MANUAL WHEN REPLACING THE CONTENTS OF BOTTLE 8 (ETHANOL). THE LEICA PELORIS/PELORIS 11 USER MANUAL CONTAINS THE FOLLOWING SPECIFIC WARNING: "ALWAYS CHANGE REAGENTS WHEN PROMPTED. ALWAYS UPDATE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT REPLACING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS." THE COMPLAINANT ALSO REPORTED THAT THE REAGENT IN BOTTLE 12, WHICH IS CONFIGURED FOR XYLENE, MAY HAVE BEEN REPLACED WITH ETHANOL RATHER XYLENE IN ERROR. BOTTLE 8 (ETHANOL) WAS USED FOR THE FINAL DEHYDRATION STEP IN EACH OF THE TWO (2) AFFECTED PROTOCOLS' AND BOTTLE 12 (XYLENE) WAS USED FOR THE FINAL CLEARING STEP IN EACH OF THE TWO (2) AFFECTED PROTOCOLS.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING SUB-OPTIMAL PROCESSING OF TISSUE IN 120 BLOCKS FROM TWO (2) PROCESSING RUNS, WHICH COMPRISED BOTH BIOPSY AND ROUTINE SAMPLES. THE COMPLAINANT DESCRIBED THE ADVERSELY AFFECTED TISSUE SAMPLES AS "UNDER-PROCESSED". THE COMPLAINANT ADVISED THAT THE PATHOLOGIST WAS NOT ABLE TO MAKE A DIAGNOSIS ON A PORTION OF THE ADVERSELY AFFECTED TISSUE SAMPLES, WITH THE FINAL STATUS OF THE REMAINING PORTION OF THE ADVERSELY AFFECTED TISSUE SAMPLES ALSO PENDING. THE COMPLAINANT ALSO ADVISED THAT THE REAGENT IN TWO (2) BOTTLES DESIGNATED AS FORMALIN AND THE XYLENE IN BOTTLE 12 HAD BEEN REPLACED PRIOR TO COMMENCEMENT OF THE AFFECTED PROCESSING RUNS. A LEICA REPRESENTATIVE FROM THE NORTH AMERICA TECHNICAL ASSISTANCE CENTER REQUESTED THE COMPLAINANT TO CHECK THAT THE REAGENT IN BOTTLE 12 HAD ACTUALLY BEEN REPLACED WITH XYLENE. THE COMPLAINANT ADVISED THAT IT WAS SUSPECTED THAT BOTTLE 12 MAY CONTAIN ALCOHOL RATHER THAN XYLENE. ON (B)(6) 2015, THE COMPLAINANT CONFIRMED THAT THE REAGENT IN BOTTLES 1 (FORMALIN), 2 (FORMALIN) AND 12 (XYLENE) HAD BEEN REPLACED ON (B)(6) 2015; AND PROVIDED THE ETHANOL CONCENTRATION MEASURED BY HYDROMETER IN BOTTLES 3-10 INCLUSIVE. THE VARIANCE BETWEEN THE MEASURED ETHANOL CONCENTRATION AND THAT CALCULATED BY THE INSTRUMENT SOFTWARE EXCEEDED THE ACCEPTABLE LIMIT FOR BOTTLE 8 (ETHANOL) ONLY. THE MEASURED ETHANOL CONCENTRATION WAS 75.7.%; AND THE CALCULATED ETHANOL CONCENTRATION WAS 99.7%. THE COMPLAINANT REPORTED THAT SUB-OPTIMAL TISSUE PROCESSING HAD BEEN IDENTIFIED FROM THE "FACTORY 8HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT B AT 15:29PM ON (B)(6) 2015 AND THE "FACTORY 8HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT A. ON (B)(6) 2015, LEICA BIOSYSTEMS RECEIVED INFO THAT A NUMBER OF TISSUE SAMPLES EXHIBITING SUB-OPTIMAL TISSUE PROCESSING WERE NOT DIAGNOSABLE FOLLOWING RE-PROCESSING. THE NUMBER OF PATIENTS INVOLVED; AND A PT IDENTIFIER, AGE AND GENDER FOR EACH CASE WAS REQUESTED. ON (B)(6) 2015, LEICA BIOSYSTEMS RECEIVED INFO CONFIRMING THAT TISSUE FROM THREE (3) PATIENTS WAS NOT DIAGNOSABLE. THE AGE AND GENDER FOR EACH PT WERE ALSO PROVIDED BY THE LABORATORY. REFER TO MFR. REPORT# 8020030-2015-00046 AND 8020030-2015-00047 FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353359 PELORIS RAPID TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention