BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESOR

    MDR report key: 6128279 · Received November 27, 2016

    Report

    Report Number
    8020030-2016-00079
    Event Type
    Injury
    Date Received
    November 27, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 1, 2016
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS COMPLAINT FOUND THAT THE CASSETTES LOADED INTO RETORT B BY A USER AT 17:08:58PM ON (B)(6) 2016 REMAINED IN THE DRY RETORT AT 65ºC UNTIL 09:37AM ON (B)(6) 2016 WHEN RETORT B WAS ACCESSED. THE TISSUE SAMPLES HAD REMAINED IN RETORT B AT 65ºC WITHOUT BEING COVERED BY REAGENT FOR APPROXIMATELY 65 HOURS. AT 17:08:50PM AND 17:08:52PM ON (B)(6), A USER ACKNOWLEDGED THE FOLLOWING INFORMATION: "INCOMPATIBLE REAGENT IN RETORT. CLEAN RETORT OR EDIT PROTOCOL, RETORT B." AT 17:10:16PM ON (B)(6) 2016, THE USER SELECTED <START>; AND THE <RUN VALIDATION CHECKS> DIALOG BOX WAS DISPLAYED TO THE USER. THE <RUN VALIDATION CHECKS> DIALOG BOX DISPLAYED THE FOLLOWING INFORMATION: "WAX RESIDUE IN RETORT B IS INCOMPATIBLE WITH FORMALIN. CLEAN RETORT OR USE "EDIT STEPS" IN SCHEDULING DIALOG TO START PROTOCOL WITH A COMPATIBLE REAGENT." THE INSTRUMENT FUNCTIONED AS DESIGNED IN THE CIRCUMSTANCES INVOLVED BY PREVENTING THE USER FROM STARTING A PROTOCOL IN RETORT B; AND NOTIFYING THE USER THAT THE PROTOCOL COULD NOT BE STARTED BECAUSE RETORT B CONTAINED WAX RESIDUE, WHICH IS INCOMPATIBLE WITH FORMALIN. THE ROOT CAUSE OF THE SUB-OPTIMAL TISSUE PROCESSING REPORTED BY THE COMPLAINANT WAS A USE ERROR, WHICH RESULTED IN UNPROCESSED TISSUE SAMPLES REMAINING IN A DRY RETORT AT 65ºC FOR APPROXIMATELY 65 HOURS. SPECIFICALLY, THE USER ACKNOWLEDGED THE INFORMATION DISPLAYED IN <RUN VALIDATION CHECKS> DIALOG BOX INDICATING THAT THE WAX RESIDUE PRESENT IN RETORT B WAS INCOMPATIBLE WITH FORMALIN; BUT THE USER DID NOT EITHER CLEAN THE RETORT OR USE "EDIT STEPS" IN THE SCHEDULING DIALOG TO START THE PROTOCOL WITH A COMPATIBLE REAGENT AS INSTRUCTED AND THE PROTOCOL BEING SCHEDULED DID NOT START.

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT REGARDING "DAMAGED" TISSUE SAMPLES. ON 02 NOVEMBER 2016, A LEICA BIOSYSTEMS REPRESENTATIVE WAS ADVISED THAT: "THE CLINICAL HEAD IS CURRENTLY MAKING HER ASSESSMENT ON THE CASES WHICH HAVE BEEN AFFECTED. AT THIS STAGE, ALL 70 CASSETTES HAVE BEEN COMPROMISED AND THEY ESTIMATE THAT ALL 10 PATIENTS WILL REQUIRE RE-BIOPSY." AN IDENTIFIER, AGE OR DATE OF BIRTH AND GENDER WAS REQUESTED FOR EACH AFFECTED PATIENT. FURTHER INFORMATION COMMUNICATED TO LEICA BIOSYSTEMS ON 02 NOVEMBER 2016 INDICATED THAT PATIENT DETAILS WOULD NOT BE PROVIDED. ON 16 NOVEMBER 2016, LEICA BIOSYSTEMS RECEIVED THE FOLLOWING STATEMENT FROM THE CLINICAL HEAD HISTOPATHOLOGY: "THE OUTCOME OF OUR INVESTIGATION INTO CLINICAL CONSEQUENCES IS THAT 3 PATIENTS HAVE REQUIRED REBIOPSY UNDER LOCAL ANESTHETIC TO REACH TISSUE DIAGNOSIS. NO SURGICAL INTERVENTION OR DEATH/SERIOUS INJURY HAS OCCURRED. THERE HAS ALSO BEEN NO IMPAIRMENT OF BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE". INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS. REFER TO MFR. REPORT# 8020030-2016-00078 AND #8020030-206-00080 FOR THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778857 PELORIS RAPID TISSUE PROCESOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention