BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOCORE PELORIS 3 RAPID TISSUE PROCESSOR

    MDR report key: 14795577 · Received June 23, 2022

    Report

    Report Number
    8020030-2022-00081
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 24, 2022
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER EVALUATION OF THE INFORMATION AVAILABLE SHOWED THAT TWO (2) CUSTOMISED AND VALIDATED TISSUE PROCESSING PROTOCOLS HAVE BEEN CONFIGURED ON HISTOCORE PELORIS 3 TISSUE PROCESSOR SERIAL NUMBER 45110582 VIZ. THE "LATE RUN" PROTOCOL WITH A DURATION OF 08:09 HOURS AND THE "RAPID" PROTOCOL WITH A DURATION OF 02:15 HOURS PROTOCOL. SECTION 8.2.1 OF THE LEICA HISTOCORE PELORIS 3 RAPID TISSUE PROCESSING SYSTEM USER MANUAL DETAILS THE RECOMMENDED PROTOCOL DURATION FOR DIFFERENT PATIENT TISSUE SAMPLE DIMENSIONS, INCLUDING MAXIMUM THICKNESS, AND DIFFERENT EXAMPLE SPECIMEN TYPES AS FOLLOWS: THE 1 HOUR PROTOCOL IS RECOMMENDED FOR TISSUE OF 1.5MM DIAMETER/MAXIMUM THICKNESS AND THE FOLLOWING EXAMPLE SPECIMEN TYPES: ENDOSCOPIES AND NEEDLE BIOPSIES OF BREAST AND PROSTATE. THE 2 HOUR PROTOCOL IS RECOMMENDED FOR TISSUE OF <3MM DIAMETER/MAXIMUM THICKNESS AND THE FOLLOWING EXAMPLE SPECIMEN TYPES: GI BIOPSIES, RENAL; PROSTATIC, HEPATIC AND BREAST CORES, PUNCH BIOPSIES OF SKIN, SMALL COLONIC POLYPS. THE 4 HOUR PROTOCOL IS RECOMMENDED FOR TISSUE OF 3MM DIAMETER/MAXIMUM THICKNESS AND THE FOLLOWING EXAMPLE SPECIMEN TYPES: SMALL SPECIMENS OF NON-DENSE TISSUES (KIDNEY, LIVER, BOWEL ETC), EXCISIONAL AN INCISIONAL SKIN BIOPSIES, SKIN ELLIPSES. THE 6-8 HOUR PROTOCOL IS RECOMMENDED FOR TISSUE OF 15X10X4MM MAXIMUM THICKNESS AND THE FOLLOWING EXAMPLE SPECIMEN TYPES: ALL ROUTINE CASES UP TO MAXIMUM DIMENSIONS (EXCLUDING BRAIN SPECIMENS). THE 12 HOUR PROTOCOL IS RECOMMENDED FOR TISSUE OF 20X10X5MM MAXIMUM THICKNESS AND THE FOLLOWING EXAMPLE SPECIMEN TYPES: ALL ROUTINE CASES UP TO MAXIMUM DIMENSIONS. VERY THICK FATTY SPECIMENS MAY REQUIRE A LONGER PROTOCOL. MANUFACTURER EVALUATION OF THE INFORMATION PROVIDED DETERMINED THAT THE ROOT CAUSE OF THE SUB-OPTIMAL PROCESSING OF PATIENT TISSUE SAMPLES REPORTED BY THE COMPLAINANT WAS USE OF A PROTOCOL OF INAPPROPRIATE DURATION FOR A PORTION OF THE SIZE(S) AND TYPES OF THE PATIENT TISSUE SAMPLES BEING PROCESSED. SPECIFICALLY, A PROTOCOL WITH A DURATION OF 08:09 HOURS IS NOT APPROPRIATE FOR PROCESSING "LARGE TISSUE" SAMPLES COMPRISING "BREAST, PLACENTA, UTERUS, COLON".

    Description of Event or Problem · 0

    THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS AND THE FOLLOWING INFORMATION WAS DOCUMENTED: "UNDER PROCESSED TISSUE. CUSTOMER REPORTED ORIGINALLY AS TISSUE NOT FIXED, HOWEVER SHE DESCRIBES ALL TISSUE IS SITTING IN FORMALIN ALL DAY BEFORE BEING PROCESSED OVERNIGHT. TISSUE IS "SOFT AND MUSHY". TWO RUNS AFFECTED FIRST RUN WAS A WEEK BEFORE LAST, CUSTOMER DOES NOT REMEMBER EXACT DATE TIMES, RET A, 15-20 BLOCKS OUT OF 200+ WERE SOFT AND MUSHY, REPROCESSED BY MELTING DOWN BLOCKS PUTTING TISSUE BACK IN FORMALIN AND REPROCESSING ON ANOTHER PROCESSOR. RET B BIOPSIES NOT AFFECTED. FOLLOWING THIS NO REAGENTS CHANGED IMMEDIATELY, EXCEPT AS PROMPTED TO CHANGE ALCOHOLS AND XYLENES. PROCESSOR USED AS NORMAL BOTH RETORTS, NO PROCESSING ISSUES UNTIL SECOND AFFECTED RUN. SECOND RUN AFFECTED WAS LAST WEDNESDAY MAY 18TH OVERNIGHT RUN RET A, 100 APPROXIMATELY OUT OF 200+ BLOCKS AFFECTED, LARGE TISSUES OF SEVERAL TYPES. TISSUE WAS AGAIN "SOFT AND MUSHY" AND ALSO HAD A BROWN DISCOLORATION, FORMALIN APPEARED OK? AFFECTED TISSUE WAS REPROCESSED AS BEFORE. RET B BIOPSIES DID NOT APPEAR AFFECTED. CUSTOMER HAS CHANGED THE FORMALIN AND LOWERED CHANGE THRESHOLD FOR FORMALIN, HAS NOT CHANGED ANY OTHER REAGENTS AFTER THIS AND NOT USED UNIT..." ON 01 JUNE 2022, THE FAS VISITED THE CUSTOMER SITE TO OBTAIN FURTHER INFORMATION AND TO PROVIDE THE NECESSARY TECHNICAL SUPPORT REQUIRED IN RELATION TO THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT. ON 03 JUNE 2022, LEICA BIOSYSTEMS (B)(6) RECEIVED INFORMATION FROM THE FAS THAT THE AFFECTED PATIENT TISSUE SAMPLES WERE "BREAST, PLACENTA, UTERUS, COLON"; THE AFFECTED PATIENT TISSUE SAMPLES WERE "SOFT AND MUSHY, BROWN DISCOLORATION" AND THE AFFECTED PATIENT TISSUE SAMPLES HAD BEEN REPROCESSED AS FOLLOWS: "REPROCESSED BY MELTING DOWN BLOCKS PUTTING TISSUE BACK IN FORMALIN AND REPROCESSING ON ANOTHER PROCESSOR." THE SPECIFIC SIZE(S) OF THE AFFECTED PATIENT TISSUE SAMPLES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454085 HISTOCORE PELORIS 3 RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD HISTOCORE PELORIS 3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown