BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6071701 · Received November 1, 2016

    Report

    Report Number
    8020030-2016-00052
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT THIS REPORT WAS SUBMITTED AS HARD COPY BY LEICA BIOSYSTEMS MELBOURNE PTY. LTD. ON (B)(4) 2016, DUE TO ERRORS ENCOUNTERED WHEN SUBMITTING THE EMDR THROUGHOUT THE AXWAY INTERCHANGE.

    Additional Manufacturer Narrative · 1

    ON 03 OCTOBER 2016, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION FROM THE LABORATORY: "REGRETFULLY WE CANNOT PROVIDE ANY DATA ON PATIENTS". DETAILS OF THE SPECIFIC PROCESSING RUNS FROM WHICH THE POORLY PROCESSED BIOPSY SAMPLES WERE DERIVED WERE NOT PROVIDED BY THE COMPLAINANT. MANUFACTURER EVALUATION OF THE INSTRUMENT LOGS SHOWED THAT: - BOTTLES 3 (70% ETHANOL) AND 4 (90% ETHANOL) WERE NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 18 MINUTES AND 10 SECONDS AND 19 MINUTES RESPECTIVELY AT 09:11AM ON (B)(6) 2016, WHICH IS SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN BOTH INSTANCES; AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATIONS WERE RESET AT 09:29AM AND 09:30AM ON (B)(6) 2016 RESPECTIVELY. RESETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITIONS UNLESS AN ALTERNATIVE VALUE IS ENTERED INTO THE INSTRUMENT SOFTWARE BY THE USER; AND RESETS THE NUMBER OF CASSETTES PROCESSED AND THE NUMBER OF CYCLES AND DAYS TO ZERO. A USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE ETHANOL CONCENTRATION IN BOTTLE 3 WAS TO BE SET TO THE DEFAULT VALUE OF 70% AT 09:29AM ON (B)(6) 2016; AND THE ETHANOL CONCENTRATION IN BOTTLE 4 WAS TO BE SET TO 90% AT 09:30AM ON (B)(6) 2016. - THE FOLLOWING FOUR (4) PROTOCOLS WERE STARTED IN THE PERIOD BETWEEN (B)(6) 2016: THE "RUTINA" PROTOCOL, WHICH STARTED IN RETORT B AT 14:16PM ON (B)(6) 2016 AND FAILED AT 19:09PM ON (B)(6) 2016; THE "RUTINA" PROTOCOL, WHICH STARTED IN RETORT B AT 17:28PM ON (B)(6) 2016 AND COMPLETED SUCCESSFULLY AT (B)(6) 2016; THE "RUTINA" PROTOCOL, WHICH STARTED IN RETORT B AT 14:25PM ON (B)(6) 2016 AND COMPLETED SUCCESSFULLY AT 07:30AM ON (B)(6) 2016 AND THE "RUTINA" PROTOCOL, WHICH STARTED IN RETORT B AT 14:01PM ON (B)(6) 2016 AND COMPLETED SUCCESSFULLY AT 07:30AM ON (B)(6) 2016. THESE PROTOCOLS COMPRISED 232, 250, 254 AND 168 CASSETTES RESPECTIVELY. - A CODE RECORDED IN THE INSTRUMENT LOGS AT 19:09PM ON (B)(6) 2016 INDICATES THAT BOTTLE 4 IS NOT CONNECTED TO THE CORRESPONDING SENSOR. THE FOLLOWING INFORMATION WAS DISPLAYED IN ASSOCIATION WITH THIS EVENT CODE: "BOTTLE NOT PRESENT; CHECK ALL BOTTLES ARE CORRECTLY INSTALLED, RETORT B, BOTTLE 4." - A CODE RECORDED IN THE INSTRUMENT LOGS AT 19:09PM ON (B)(6) 2016 INDICATES THAT THE "RUTINA" PROTOCOL IN RETORT B HAS FAILED AND 70% ETHANOL REMAINS IN RETORT B. THE <INSERTED DIALOG CONFIGURATION> BOX WOULD HAVE BEEN DISPLAYED ON THE INSTRUMENT MONITOR. - BOTH LOCAL AND REMOTE ALARMS WERE ACTIVATED AT 19:09PM ON (B)(6) 2016. - A USER INTERACTED WITH THE INSTRUMENT AT 08:07AM ON (B)(6) 2016 BY SELECTING THE <CHANGED> RADIO BUTTON FROM THE THREE (3) AVAILABLE RADIO BUTTONS, WHICH RESULTED IN OPENING OF THE <DEFAULT CONCENTRATION> DIALOG BOX WITH THE FOLLOWING MESSAGE DISPLAYED: "DO YOU WANT TO USE THE DEFAULT CONCENTRATION FOR THIS REAGENT?" THE USER SELECTED THE <YES> RADIO BUTTON. AS THE REAGENT IN BOTTLE 4 HAD NOT BEEN USED SINCE IT WAS REPLACED ON (B)(6) 2016, THIS USER ACTION DID NOT EITHER CAUSE OR CONTRIBUTE TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED. THE ROOT CAUSE FOR FAILURE OF THE "RUTINA" PROTOCOL STARTED IN RETORT B AT 14:16PM ON (B)(6) 2016 AT 19:09PM ON (B)(6) 2016, WHICH WAS AT THE COMMENCEMENT OF STEP 3 OF THE PROTOCOL, WAS THAT BOTTLE 4 (90% ETHANOL) WAS DISCONNECTED FROM THE CORRESPONDING SENSOR. THE INSTRUMENT FUNCTIONED AS DESIGNED IN THIS CIRCUMSTANCE BY ABANDONING THE PROTOCOL; RECORDING AN ERROR CODE IN THE INSTRUMENT LOGS; ACTIVATING BOTH THE LOCAL AND REMOTE ALARMS AND LEAVING THE TISSUE SAMPLES IN RETORT B COVERED WITH 70% ETHANOL FROM BOTTLE 3, WHICH HAD BEEN USED FOR STEP 2 OF THE PROTOCOL. THE ROOT CAUSE OF BOTTLE 4 BEING DISCONNECTED FROM THE CORRESPONDING SENSOR COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING POORLY PROCESSED BIOPSIES. THE COMPLAINANT DESCRIBED THE AFFECTED TISSUE SAMPLES AS "BURNED". ON (B)(6) 2016, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING INFORMATION FROM THE LABORATORY "TWO PATHOLOGISTS HAVE EVALUATED ALL SAMPLES WITH LIMITATIONS IN THE DIAGNOSIS DUE TO THE PROCESSING. ONE HAS 4-5 PATIENTS COULD NOT BE DIAGNOSED. ONE LIVER BIOPSY HAS TO BE REQUESTED AGAIN. ONE PATHOLOGIST CAN'T GIVE A DIAGNOSIS IN ONE BONE MARROW". AN IDENTIFIER; AGE OR DATE OF BIRTH AND GENDER OF EACH PATIENT REQUIRING RE-BIOPSY WILL BE SOUGHT. INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721726 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention