BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2220634 · Received June 27, 2011

    Report

    Report Number
    8020030-2011-00038
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 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 COMPLAINT INVESTIGATION PROCESS. ON-SITE ASSESSMENT OF THE OPERATION AND FUNCTION OF THE INSTRUMENT WAS CONDUCTED BY A LEICA FIELD SVC ENGINEER (FSE) ON (B)(4) 2011. NO INSTRUMENT FAULT (S) WAS IDENTIFIED. THE FSE ADVISED THE LAB THAT ALL REAGENTS SHOULD BE REPLACED AND THAT THE QUALITY OF TISSUE PROCESSING SHOULD BE ASSESSED USING NON-CLINICAL TISSUE PRIOR TO PROCESSING ANY FURTHER PT SAMPLES. SEVERAL EXAMPLES INVOLVING FAILURE BY THE USER TO FOLLOW THE INSTRUCTIONS FOR USE AS DETAILED IN THE PELORIS USER MANUAL, WHICH MAY HAVE CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED, WERE IDENTIFIED AS FOLLOWS: BOTTLE 10 (IPA) WAS REMOVED FROM THE INSTRUMENT FOR LESS THAN THE MINIMUM TIME OF 1 MINUTE REQUIRED FOR AN EXPERIENCED USER TO COMPLETE MANUAL REAGENT REPLACEMENT, AND THE REAGENT STATION WAS RESET. RESETTING THE REAGENT STATION SETS THE REAGENT CONCENTRATION OF THE DEFAULT VALUE OF 100%, AND AUTOMATICALLY RESETS THE NUMBER OF CASSETTES PROCESSED, DAYS AND CYCLES TO ZERO. A NON-VALIDATED PROTOCOL WAS USED WHEN RE-PROCESSING TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING. ON (B)(4) 2011, PRIOR TO COMMENCEMENT OF THE RE-PROCESSING PROTOCOLS, ALL BOTTLES WERE REMOVED FOR SUFFICIENT TIME TO ALLOW COMPLETION OF MANUAL REAGENT REPLACEMENT, AND EACH OF THE ASSOCIATED REAGENT STATIONS WAS RESET. AS A CONSEQUENCE, THE DEFAULT CONCENTRATION OF 100% WAS SET FOR EACH REAGENT STATION AND NO GRADED ALCOHOLS WERE AVAILABLE AS RECOMMENDED BY THE MFR. FOLLOWING RE-PROCESSING THE COMPLAINANT DESCRIBED THE TISSUE AS "BURNT," AND THE LACK OF GRADED ALCOHOLS MAY HAVE CONTRIBUTED TO THIS RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A PROTOCOL(S) WHICH COMMENCED ON (B)(6) 2011 AND COMPLETED ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). THE COMPLAINANT ADVISED THAT BIOPSY SAMPLES WERE PROCESSED IN ONE RETORT AND LARGE TISSUE SAMPLES IN THE SECOND RETORT, AND THAT AND LARGE TISSUE SAMPLES WERE FOUND TO BE "MUSHY" WITH A GRITTY RESIDUE. ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED INFO THAT TWO (2) BLOCKS COMPROMISING LYMPH NODE TISSUE WERE NOT DIAGNOSABLE. INFO REGARDING WHETHER RE-BIOPSY IS REQUIRED AND/OR HAS BEEN PERFORMED IS NOT AVAILABLE TO DATE.

    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