BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 6071753 · Received November 2, 2016

    Report

    Report Number
    8020030-2016-00061
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 12, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT FOUND THAT THE INSTRUMENT OPERATED WITHIN SPECIFICATION DURING EXECUTION OF BOTH THE "OVERNIGHT BREAST BIOPSY" PROTOCOL STARTED IN RETORT A AT 17:48PM ON (B)(6) 2016 AND THE "GI/NEEDLE CORE OVERNIGHT" PROTOCOL STARTED IN RETORT B AT 17:49PM ON (B)(6) 2016, FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. IT WAS DETERMINED THAT THE REQUIREMENT TO RE-START THE INSTRUMENT BECAUSE THE UPS DID NOT SUPPORT THE INSTRUMENT FOR THE DURATION OF THE POWER OUTAGE, WHICH THE COMPLAINANT REPORTED HAD OCCURRED "LATER ON SATURDAY" (B)(6) 2016, DID NOT EITHER CAUSE OR CONTRIBUTE TO THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BECAUSE THE PROCESSING RUNS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED COMPLETED AT 03:45AM ON (B)(6) 2016. AN ERROR RECORDED ON TWO (2) OCCASIONS AT 17:46PM ON (B)(6) 2016 INDICATES THAT THE PROTOCOL BEING SCHEDULED BY THE USER COULD NOT BE RUN BECAUSE NONE OF THE BOTTLES DESIGNATED FOR ALCOHOL CONTAINED REAGENT AT A CONCENTRATION EITHER AT, OR ABOVE, THE MINIMUM REQUIRED FOR USE AS THE FINAL REAGENT. THE FOLLOWING INFORMATION WAS ALSO DISPLAYED: "CANNOT RUN PROTOCOL; FINAL CONCENTRATION THRESHOLD FOR ALCOHOL EXCEEDED. REPLACE LEAST PURE ALCOHOL STATION, BOTTLE 3." AN ERROR CODE RECORDED AT 17:47PM ON (B)(6) 2016 INDICATES THAT BOTTLE 3 (ALCOHOL) WAS NOT IN CONTACT WITH THE CORRESPONDING SENSOR FOR 3 SECONDS, WHICH IS NOT SUFFICIENT TIME TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT; AND THE PROPERTIES OF THE CORRESPONDING REAGENT STATION WERE RESET AT 17:47PM ON (B)(6) 2016. RESETTING A REAGENT STATION SETS THE CONCENTRATION TO THE DEFAULT VALUE CONFIGURED IN THE REAGENT TYPES DEFINITION 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. THE PROPERTIES OF THE REAGENT IN BOTTLE 3 PRIOR TO THIS USER ACTION WERE: ALCOHOL CONCENTRATION = 55.2%, CYCLES = 58, CASSETTES = 1296, DAYS = 22. AT 17:47PM ON (B)(6) 2016, A USER AFFIRMED IN THE INSTRUMENT SOFTWARE THAT THE DEFAULT CONCENTRATION OF 100% WAS TO BE SET FOR BOTTLE 3 (ALCOHOL). AS THE INSTRUMENT SOFTWARE USES REAGENT CONCENTRATION TO SELECT REAGENT STATIONS WHEN A PROTOCOL IS SCHEDULED, THE REAGENT STATION WITH THE LOWEST (IN -THRESHOLD) CONCENTRATION OF A REAGENT GROUP OR TYPE IS SELECTED FOR THE FIRST STEP USING THAT REAGENT GROUP OR TYPE. REAGENT STATIONS OF INCREASING CONCENTRATION ARE USED FOR THE SUCCEEDING PROCESSING STEPS OF THE REAGENT GROUP OR TYPE; AND REAGENT WITH THE HIGHEST CONCENTRATION IS ALWAYS USED FOR THE FINAL PROCESSING STEP OF A REAGENT GROUP OR TYPE BEFORE CHANGING TO ANOTHER REAGENT GROUP OR TYPE. AS A CONSEQUENCE, BOTTLE 3 (ALCOHOL) WAS USED FOR THE FINAL DEHYDRATION STEP IN "OVERNIGHT BREAST BIOPSY" PROTOCOL STARTED IN RETORT A AT 17:48PM ON (B)(6) 2016 AND THE "GI/NEEDLE CORE OVERNIGHT" PROTOCOL STARTED IN RETORT B AT 17:49PM ON (B)(6) 2016. THE MINIMUM FINAL REAGENT CONCENTRATION REQUIRED FOR ETHANOL IS 98%. THE CONSEQUENCES OF USING ETHANOL AT A CONCENTRATION LESS THAN THE MINIMUM REQUIRED FOR THE FINAL DEHYDRATION STEP IN A PROTOCOL IS RE-INTRODUCTION OF WATER INTO THE TISSUE WHICH CANNOT BE DISPLACED IN SUBSEQUENT PROCESSING STEPS; AND CONTAMINATION OF REAGENTS USED IN THE SUBSEQUENT PROCESSING STEPS, ULTIMATELY RESULTING IN SUB-OPTIMAL TISSUE PROCESSING. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED WAS A USE ERROR, WHICH OCCURRED PRIOR TO COMMENCEMENT OF THE PROTOCOLS FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. SPECIFICALLY, A USER FAILED TO COMPLETE MANUAL REPLACEMENT OF THE REAGENT IN BOTTLE 3 (ALCOHOL) IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS DETAILED IN THE LEICA PELORIS/PELORIS LL USER MANUAL. THE LEICA PELORIS/PELORIS LL USER MANUAL CONTAINS THE FOLLOWING SPECIFIC WARNING: "ALWAYS CHANGE REAGENTS WHEN PROMPTED. ALWAYS UPDATE STATION DETAILS CORRECTLY - NEVER UPDATE THE DETAILS WITHOUT REPLACING THE REAGENT. FAILURE TO FOLLOW THESE DIRECTIVES CAN LEAD TO TISSUE DAMAGE OR LOSS."

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT TISSUE IN 45 CASSETTES, WHICH HAD BEEN PROCESSED OVERNIGHT ON FRIDAY THROUGH TO SATURDAY IN RETORT A AND B, WAS VERY "BURNT" AND DEHYDRATED. THE COMPLAINANT ADVISED THAT THE REAGENT IN EACH OF TWO (2) BOTTLES WAS REPLACED WITH EITHER 70% ALCOHOL AND 90% ALCOHOL ON SATURDAY; THE QUALITY OF TISSUE PROCESSING FROM A VALIDATION RUN COMPRISING A SINGLE BLOCK, WHICH WAS PERFORMED FOLLOWING REPLACEMENT OF THE REAGENT IN THE TWO (2) BOTTLES, WAS SATISFACTORY AND A POWER OUTAGE IN THE BUILDING "LATER ON SATURDAY" NECESSITATED RE-START OF THE INSTRUMENT AS THE UPS WAS UNABLE TO SUPPORT THE INSTRUMENT FOR THE DURATION OF THE POWER OUTAGE. ON (B)(6) 2016, LEICA BIOSYSTEMS RECEIVED INFORMATION THAT TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WOULD BE UN-DIAGNOSABLE. THE NUMBER OF UNDIAGNOSABLE SAMPLES WAS NOT PROVIDED. ON (B)(6) 2016, LEICA BIOSYSTEMS RECEIVED FURTHER INFORMATION THAT SEVEN (7) CASES WERE UN-DIAGNOSABLE AND WOULD REQUIRE RE-BIOPSY. AN IDENTIFIER, THE AGE AND THE GENDER FOR EACH PATIENT REQUIRING RE-BIOPSY WAS PROVIDED. (B)(6). REFER TO #8020030-2016-00062; #8020030-2016-00063; #8020030-2016-00064; #8020030-2016-00065; #8020030-2016-00066; AND #8020030-2016-00067 FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723382 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention