BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2024250 · Received March 3, 2011

    Report

    Report Number
    8020030-2011-00013
    Event Type
    Malfunction
    Date Received
    March 3, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: THE CONFIGURATION OF THE REAGENT STATIONS AND THE FINAL REAGENT THRESHOLDS ARE IDENTICAL TO THE MANUFACTURER RECOMMENDATIONS. THE REAGENT CHANGE THRESHOLDS, REAGENT MANAGEMENT PARAMETERS AND CONFIGURATION OF THE VALIDATED PROTOCOL USED TO PROCESS TISSUE SAMPLES IN THE RUN EXHIBITING SUB-OPTIMAL PROCESSING WERE SIMILAR, BUT NOT IDENTICAL, TO THE MANUFACTURER RECOMMENDATIONS. HOWEVER, THE DIFFERENCES IDENTIFIED WERE NOT CONSIDERED TO HAVE EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. INFORMATION DISPLAYED TO THE OPERATOR INDICATED THAT A PROTOCOL(S) COULD NOT BE SCHEDULED BECAUSE THE FINAL NUMBER OF CASSETTES PROCESSED THRESHOLD HAD BEEN EXCEEDED FOR REAGENT STATIONS 3-10 (ETHANOL) INCLUSIVE. IN RESPONSE, THE OPERATOR CHANGED THE CALCULATED CONCENTRATION VALUE FOR EACH OF THESE STATIONS USING THE SOFTWARE ONLY WITHOUT ACTUALLY REPLACING THE REAGENT IN THE BOTTLES, WHICH WAS AN INCORRECT ACTION. BOTTLES 7 AND 8 (ETHANOL) WERE SUBSEQUENTLY REMOVED FROM THE CORRESPONDING BOTTLE SENSOR FOR INSUFFICIENT TIME TO CORRECTLY COMPLETE THE REAGENT REPLACEMENT PROCESS AND THE STATION PROPERTIES WERE THEN RESET. BOTTLE 8 WAS SUBSEQUENTLY USED FOR THE FINAL DEHYDRANT STEP IN THE RUN EXHIBITING SUB-OPTIMAL PROCESSING, AND THE LOGS SHOW THAT THE ACTUAL ETHANOL CONCENTRATION IS 98%. AS A CONSEQUENCE, WATER WOULD BE RE-INTRODUCED INTO THE TISSUE LEADING TO CONTAMINATION OF REAGENTS AND WAX USED IN SUCCEEDING PROCESSING STEPS RESULTING IN THE SUB-OPTIMAL TISSUE PROCESSING REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM TISSUPATH REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A PROTOCOL RUN ON (B)(6) USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED INFORMATION THAT ALL SAMPLES PROCESSED IN THE RUN EXHIBITING SUB-OPTIMAL TISSUE 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