BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2024225 · Received February 23, 2011

    Report

    Report Number
    8020030-2011-00012
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT LOGS WERE EVALUATED AS PART OF THE INVESTIGATION OF THIS COMPLAINT. THE LOGS SHOW THAT THE CONFIGURATION OF THE REAGENT STATIONS, REAGENT CHANGE AND FINAL REAGENT THRESHOLDS, REAGENT MANAGEMENT AND THE CONFIGURATION OF THE PROTOCOL USED TO PROCESS TISSUE SAMPLES IN THE RUNS EXHIBITING SUB-OPTIMAL TISSUE PROCESSING WERE SIMILAR, BUT NOT IDENTICAL, TO THE MFR RECOMMENDATIONS. THE DIFFERENCES IDENTIFIED WERE NOT CONSIDERED TO HAVE EITHER CAUSED OR CONTRIBUTED TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. LOOSE TUBING WAS IDENTIFIED BETWEEN THE RETORTS AND THE PRESSURE TRANSDUCERS, THE TRANSDUCERS AND THE AIR MANIFOLD AND AT THE T-CONNECTORS ON THE COMPRESSOR ASSEMBLY. LOWER LIQUID LEVEL SENSOR IN RETORT A WAS FOUND TO BE FAULTY. A CONCLUSION COULD NOT BE DRAWN DUE TO THE LIMITATIONS OF THE INFO AVAILABLE TO CONDUCT THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM TWO (2) PROTOCOLS STARTED ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR (B)(4). LEICA MICROSYSTEM WAS ALSO ADVISED THAT ALL TISSUE SAMPLES PROCESSED ON THESE RUNS 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