BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2011941 · Received February 11, 2011

    Report

    Report Number
    8020030-2011-00009
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 14, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION PROCESS. THE INSTRUMENT LOGS SHOWED THAT THE CONFIGURATION OF THE REAGENT STATIONS, THE REAGENT THRESHOLDS AND PROTOCOL CONFIGURATION DIFFERED FROM THE CURRENT MANUFACTURER RECOMMENDATIONS. THE DIFFERENCES IDENTIFIED WERE NOT CONSIDERED BY LEICA MICROSYSTEMS (B)(6) 2011 TO HAVE EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. INVESTIGATION OF THE COMPLAINT IDENTIFIED THAT TISSUE SAMPLES WERE EXPOSED TO THE RESIDUAL HEAT IN THE RETORT FOR 30 MINUTES AFTER COMPLETION OF THE PROTOCOL FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE INSTRUMENT SOFTWARE PROMPTS THE OPERATOR TO DRAIN THE WAX FROM THE RETORT AT THE COMPLETION OF A PROTOCOL, AND WHEN THIS ACTION IS COMPLETED THE SOFTWARE INSTRUCTS THE OPERATOR TO REMOVE THE TISSUE FROM THE RETORT. THE PRACTICE OF EXPOSING TISSUE SAMPLES TO THE RESIDUAL HEAT IN THE RETORT FOR AN EXTENDED PERIOD AFTER COMPLETION OF THE PROCESSING PROTOCOL IS NOT DESIRABLE, AND IS CONSIDERED LIKELY TO HAVE CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED IN THIS COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM THE (B)(6) HOSPITAL INSTITUTE OF PATHOLOGY REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A PROTOCOL RUN ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). THE MACROSCOPIC DESCRIPTION OF THE TISSUE WAS HARD, DIFFICULT TO CUT AND APPEARED DRY; AND THE MICROSCOPIC DESCRIPTION OF THE TISSUE MORPHOLOGY WAS POOR AND HYPER-EOSINOPHILIC WITH AGGREGATED ERYTHROCYTES. THE HOSPITAL ALSO STATED THAT SUB-OPTIMAL TISSUE PROCESSING WAS ALSO NOTED ON (B)(6) 2010, (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010.

    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