BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2070545 · Received April 13, 2011

    Report

    Report Number
    8020030-2011-00022
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE INVESTIGATION OF THIS COMPLAINT. THE INSTRUMENT LOGS SHOW THAT IMMEDIATELY PRIOR TO COMMENCEMENT OF THE PROTOCOLS FROM WHICH SUB-OPTIMAL PROCESSING WAS IDENTIFIED, BOTTLE 6 (B)(4) AND BOTTLE 9 (IPA) WERE REMOVED FROM THE CORRESPONDING BOTTLE SENSORS FOR APPROXIMATELY (B)(4) AND (B)(4) RESPECTIVELY. IN BOTH CASES, THE USER SELECTED THE <CHANGED> OPTION FROM THE <INSERTED BOTTLE CONFIGURATION> DIALOG BOX DISPLAYED, AFFIRMED THAT THE DEFAULT CONCENTRATION OF 100% WAS TO BE APPLIED AND THEN RESET THE STATION PROPERTIES. AS BOTTLES 6 AND 9 WERE NOT REMOVED FROM THE INSTRUMENT FOR SUFFICIENT TIME TO REPLACE THE CONTENTS, THE ACTUAL REAGENT CONCENTRATION REMAINED AS (B)(4) AND (B)(4) RESPECTIVELY. THE PELORIS TISSUE PROCESSOR USER MANUAL, WHICH MAY BE ACCESSED FROM THE ON-BOARD COMPUTER STATES THAT THE <CHANGED> OPTION SHOULD BE SELECTED ONLY WHEN THE CONTENTS OF A BOTTLE HAVE BEEN REPLACED. INTERMITTENT MALFUNCTION OF A LIQUID LEVEL SENSOR (LLS) IN RETORT B WAS EVIDENT FROM EVALUATION OF THE INSTRUMENT LOGS. BOTTLE 9 (IPA) WAS USED FOR THE FINAL CLEARING STEP IN THE PROTOCOLS FROM WHICH SUB-OPTIMA PROCESSING WAS IDENTIFIED. THE FINAL REAGENT THRESHOLD REQUIRED FOR IPA IS (B)(4). THE CONSEQUENCES OF USING REAGENT WITH A CONCENTRATION LESS THAN THAT REQUIRED FOR THE FINAL STEP OF A PARTICULAR REAGENT GROUP OR TYPE IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED BY THE SUBSEQUENT WAX STEPS AND WAX CONTAMINATION, RESULTING IN SUB-OPTIMAL TISSUE PROCESSING. INTERMITTENT MALFUNCTION OF THE LLS MAY HAVE CONTRIBUTED TO THE SUB-OPTIMAL PROCESSING REPORTED FOR THE PROTOCOL IN RETORT B ONLY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) REGARDING SUB-OPTIMAL PROCESSING RESULTING IN UNDER-PROCESSED TISSUE, FROM TWO (2) PROTOCOLS WHICH COMMENCED ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR (B)(4). LEICA MICROSYSTEMS HAS NOT BEEN ADVISED WHETHER ALL TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WERE ABLE TO BE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1