BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 7322775 · Received March 8, 2018

    Report

    Report Number
    8020030-2018-00008
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 6, 2018
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY.LTD
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS CONSIDERED THAT USE OF "20% NBF" RATHER THAN "4% NBF" (AS REPORTED BY THE COMPLAINANT) IS LIKELY TO ACCOUNT FOR BOTH THE PRESENCE OF FORMALIN SALT RESIDUE IN THE INSTRUMENT RETORT; AND THE DIFFICULTY IN SECTIONING THE TISSUE SAMPLES PROCESSED USING THE ROUTINE OVERNIGHT 1" PROTOCOL STARTED IN RETORT B AT 16:27 PM ON (B)(6) 2018, AS REPORTED BY THE COMPLAINANT. THE ROOT CAUSE FOR THE REPORTED PRESENCE OF FORMALIN SALT RESIDUE IN THE RETORT OF PELORIS II TISSUE PROCESSOR SERIAL (B)(4) AND THE DIFFICULTY IN SECTIONING THE TISSUE SAMPLES PROCESSED IN THE "ROUTINE OVERNIGHT 1" PROTOCOL STARTED IN RETORT B AT 16:27 ON (B)(6) 2018 WAS A USE ERROR REPORTED BY THE COMPLAINANT, IN WHICH INTERNAL LABORATORY INVESTIGATION HAD IDENTIFIED A MIX UP WITH THE FORMALIN SUPPLY INVOLVING 20% NEUTRAL BUFFERED FORMALIN (NBF) BEING USED RATHER THAN 4% NBF IN ERROR.

    Description of Event or Problem · 1

    THE LEICA FIELD SUPPORT SCIENTIST - TEAM LEADER UK (FSS) RECEIVED A COMPLAINT REGARDING THE PRESENCE OF FORMALIN SALT RESIDUE BOTH IN THE RETORT AND CONTAMINATING TISSUE SAMPLES PROCESSED USING A "ROUTINE OVERNIGHT" PROTOCOL, WHICH STARTED ON (B)(6) 2018. THE COMPLAINANT REPORTED THAT THE PRESENCE OF THE FORMALIN SALT RESIDUE IN THE TISSUE SAMPLES WAS CAUSING DIFFICULTY IN SECTIONING THE TISSUE SAMPLES; AND INTERNAL INVESTIGATION HAD IDENTIFIED A MIX UP WITH THE FORMALIN SUPPLY WITH 20% NEUTRAL BUFFERED FORMALIN (NBF) HAD BEEN USED IN ERROR RATHER THAN 4% NBF. ON 14 FEBRUARY 2018, THE FSS DOCUMENTED INFORMATION PROVIDED BY THE COMPLAINANT THAT: "...FROM WHAT THEY TOLD ME OVER THE PHONE, ALL TISSUE HAS BEEN REPORTABLE ALTHOUGH THEY ARE STILL WAITING ON ALL CASES TO BE REPORTED AND FEEDBACK PROVIDED FROM THE PATHOLOGISTS." AS AT 16 FEBRUARY 2018, THE FINAL STATUS OF THE TISSUE SAMPLES INVOLVED IN THIS EVENT AND THE PATIENT OUTCOME HAD NOT BEEN PROVIDED; AND NO CONSEQUENCES TO A PATIENT(S) HAD BEEN REPORTED TO THE MANUFACTURER. AS AT 08 MARCH 2018, NO FURTHER INFORMATION HAS BEEN RECEIVED BY LEICA BIOSYSTEMS REGARDING EITHER THE FINAL STATUS OF THE TISSUE SAMPLES INVOLVED IN THIS EVENT OR THE PATIENT OUTCOME, DESPITE SEVERAL REQUESTS TO THE COMPLAINANT. NO CONSEQUENCES TO A PATIENT(S) HAVE BEEN REPORTED TO THE MANUFACTURER TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169091 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY.LTD PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1