BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 4898177 · Received July 1, 2015

    Report

    Report Number
    8020030-2015-00064
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT WAS DERIVED FROM THE "EXTENDED O'N RUN (FATTY SPECIMENS)" PROTOCOL STARTED IN RETORT A AT 15:33 PM ON (B)(6) 2015 AND THE "RENAL BIOPSY" PROTOCOL STARTED IN RETORT B AT 10:13AM ON (B)(6) 2015. THESE PROTOCOLS, WHICH COMPRISED 90 CASSETTES AND ONE CASSETTE RESPECTIVELY BASED ON DATA ENTERED BY THE USER, COMPLETED SUCCESSFULLY AND HAVE BEEN VALIDATED BY THE LABORATORY. THERE IS NO EVIDENCE OF A USE ERRORS IN THE INTERACTION BETWEEN THE USER AND THE DEVICE, EITHER PRIOR TO, OR DURING EXECUTION OF EITHER THE "EXTENDED O/N RUN (FATTY SPECIMENS)" PROTOCOL STARTED IN RETORT A AT 15:33PM ON (B)(6) 2015 OR THE "RENAL BIOPSY" PROTOCOL STARTED IN RETORT B AT 10:13AM ON (B)(6) 2015, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED BY THE COMPLAINANT. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT: "SOME POOR PROCESSING WAS NOTICED ON THE FRIDAY MORNING RUN, HOWEVER THE SPECIMENS CUT FINE. ON THE 22/06 THE CUSTOMER RAN AN URGENT RENAL BX AND THE SPECIMEN WAS DAMAGED AND NOT REPORTABLE. LAB ADVISED THE SURGEON THAT A RE-BIOPSY WAS NECESSARY." ON-SITE ASSESSMENT OF THE OPERATION AND FUNCTION OF THE INSTRUMENT WAS CONDUCTED BY A LEICA FIELD SERVICE ENGINEER (FSE) ON (B)(6)2015. THE COMPLAINANT CONFIRMED TO THE FSE THAT POOR PROCESSING HAD BEEN IDENTIFIED FROM THE "EXTENDED O/N" PROTOCOL, WHICH COMPLETED ON FRIDAY (B)(6) 2015 AT 7:12AM. THE FSE REVIEWED THE INSTRUMENT LOGS AND FOUND THAT NO ERROR CODES HAD BEEN RECORDED; NOTED THAT NO REAGENTS APPEARED CONTAMINATED ON VISUAL INSPECTION AND MEASURED THE ETHANOL CONCENTRATION IN BOTTLES 3-8 INCLUSIVE USING A HYDROMETER. THE VARIANCE BETWEEN THE MEASURED AND CALCULATED ETHANOL CONCENTRATION WAS WITHIN ACCEPTABLE LIMITS IN ALL INSTANCES. THE FSE ALSO CONDUCTED SYSTEM VERIFICATION TESTS, FOR WHICH ALL RESULTS WERE SATISFACTORY. THE FSE ADVISED THE COMPLAINANT TO REPLACE ALL REAGENTS ON THE INSTRUMENT AND THEN TO PERFORM A VALIDATION RUN USING NON-DIAGNOSTIC TISSUE, IN ORDER TO CONFIRM THAT THE QUALITY OF TISSUE PROCESSING WAS SATISFACTORY PRIOR TO PROCESSING ANY FURTHER DIAGNOSTIC SAMPLES. ON (B)(6)2015, A LEICA PRODUCT APPLICATIONS SPECIALIST (PAS) ALSO PROVIDED TECHNICAL SUPPORT TO THE LABORATORY BY TELEPHONE IN ASSOCIATION WITH THIS COMPLAINT. THE COMPLAINANT REPORTED TO THE PAS THAT THE REAGENT IN ALL BOTTLES DESIGNATED AS HISTOLENE HAD BEEN REPLACED ON FRIDAY (B)(6)2015 FOLLOWING IDENTIFICATION OF SUB-OPTIMAL TISSUE PROCESSING FROM THE "EXTENDED O/N" PROTOCOL, WHICH COMPLETED ON FRIDAY (B)(6) 2015 AT 7:12AM; AND THAT A BOTTLES CONTAINING 50/50 ETHANOL/XYLENE WAS ON THE INSTRUMENT BUT HAD NOT BEEN USED IN THE PROTOCOL USED TO PROCESS THE UNREPORTABLE RENAL BIOPSY SAMPLE. ON (B)(6) 2015, THE COMPLAINANT REPORTED THAT ALL REAGENTS WERE REPLACED ON THE EVENING OF (B)(6) 2015; AND THE QUALITY OF TISSUE PROCESSING FROM VALIDATION RUNS COMPLETED IN BOTH RETORT A AND B WAS SATISFACTORY. THE COMPLAINANT ALSO REPORTED THE FOLLOWING IN RELATION TO THE UNREPORTABLE RENAL BIOPSY SAMPLE: "THE CLINICIANS WERE ALSO QUESTIONING VASCULITIS AND FOR THAT REASON WHEN THE BIOPSY FAILED WE HAD TO PERFORM ANOTHER BIOPSY ON THE PATIENT ON THE SAME DAY WHICH IS HIGHLY UNUSUAL FOR ARENAL BIOPSY DUE TO POTENTIAL COMPLICATIONS FROM BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429627 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention