BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2423930 · Received December 22, 2011

    Report

    Report Number
    8020030-2011-00076
    Event Type
    Malfunction
    Date Received
    December 22, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: EVENT CODES RECORDED IN THE LOGS AT 18:52PM AND 18:53PM ON (B)(6) 2011 FOR MANUAL REPLACEMENT OF REAGENT IN BOTTLES 1 (FORMALIN) AND 10 (ETHANOL) RESPECTIVELY, INDICATE THAT THESE BOTTLES WERE REMOVED FROM THE INSTRUMENT FOR LESS THAN THE MINIMUM TIME REQUIRED TO COMPLETE MANUAL REAGENT REPLACEMENT. THE ASSOCIATED REAGENT STATION WAS THEN RESET TO THE DEFAULT CONCENTRATION OF 100%. (B)(4). (B)(4). INFORMATION REGARDING THE QUALITY OF TISSUE PROCESSING FROM THE "7HR XYLENE STANDARD" PROTOCOL STARTED IN ROTORT A AT 20:05PM ON (B)(4) 2011 WAS NOT PROVIDED. THE ROOT CAUSE FOR THE SUB-OPTIMAL TISSUE PROCESSING REPORTED FROM THE "7HR XYLENE STANDARD" PROTOCOL STARTED IN RETORT A AT 18:21PM ON (B)(4) 2011 WAS A USE ERROR. SPECIFICALLY, THE USER FAILED TO COMPLETE MANUAL REAGENT REPLACEMENT IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/LEICA PELORIS 11 USER MANUAL, WHICH CONTAINS THE FOLLOWING SPECIFIC WARING IN RELATION TO REAGENT REPLACEMENT ON PAGES 10 AND 95: "ALWAYS UPDATE THE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT REPLACING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS." THE CONSEQUENCES OF USING ETHANOL AT A CONCENTRATION LESS THAN THAT REQUIRED IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH IS NOT DISPLACED IN SUBSEQUENT STEPS AND REAGENT CONTAMINATION, ULTIMATELY RESULTING IN SUB-OPTIMAL PROCESSING.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) MEDICAL GROUP INC. REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A SEVEN (7) HOUR PROTOCOL, WHICH STARTED ON (B)(6) 2011 AND COMPLETED ON (B)(6) 2011 USING A PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). AT THE TIME OF NOTIFYING LEICA MICROSYSTEMS OF THIS COMPLAINT, THE COMPLAINANT ADVISED THAT ALL TISSUE EXHIBITING SUB-OPTIMAL PROCESSING WAS DIAGNOSABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1