BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2011944 · Received February 9, 2011

    Report

    Report Number
    8020030-2011-00008
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION PROCESS. INVESTIGATION OF THE COMPLAINT DETERMINED THAT THE USER FAILED TO REMOVE THE TISSUE PROCESSED IN THE "BIOPSY RUN" COMPLETED ON (B)(6) 2011, FROM THE RETORT BEFORE COMMENCING THE SUBSEQUENT QUICK CLEAN PROTOCOL. THE CONSEQUENCE OF THIS INCORRECT USER ACTION WAS THAT THE PROCESSED TISSUE SAMPLES WERE EXPOSED TO CLEANING XYLENE AT A CONCENTRATION OF 96.19% (AS CALCULATED BY THE INSTRUMENT) FOR A PERIOD OF APPROXIMATELY 2 MINUTES, CAUSING XYLENE CONTAMINATION AND A NEGATIVE IMPACT ON WAX INFILTRATION OF THE TISSUE, MANIFESTING AS UNDER-PROCESSED TISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(4) MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) HOSPITAL REGARDING SUB-OPTIMAL PROCESSING RESULTING IN UNDER-PROCESSED TISSUE FROM A PROTOCOL RUN ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR (B)(4).

    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