MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number PELORIS II

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 12/30/2019

Event Type  Injury  

Manufacturer Narrative

The root cause of the sub-optimal tissue processing reported by the complainant was a use error, which occurred at 19:58pm on (b)(6) 2019.The facts indicate that a user did not complete manual replacement of the reagent in bottle 6 (ethanol) in accordance with the manufacturer instructions detailed in the leica peloris/peloris ll user manual when event codes indicating that a protocol could not be run were displayed, because the final concentration threshold for ethanol had been exceeded.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." manufacturer evaluation of the instrument logs showed that event code "16" and the associated messaging alerting the user that the final concentration threshold for ethanol had been exceeded and to replace the reagent in bottle 6 was displayed at 14:57pm and 15:04pm on (b)(6) 2019.Event code "18" and the following associated messaging: "cannot run protocol; final concentration threshold for ethanol exceeded.Replace least pure ethanol station, bottle 6." subsequently displayed to the user on four (4) occasions between 19:57pm and 19:58pm on (b)(6) 2019.At 19:57pm on (b)(6) 2019, bottle 6 (ethanol) was not in contact with the corresponding sensor for approximately eight (8) seconds, which is not sufficient time to replace the reagent; and the station properties were reset at 19:58pm on (b)(6) 2019, with a user affirming in the instrument software that the ethanol concentration in bottle 6 was to be set to the default concentration of 100%.The properties of the reagent bottle in 6 prior to this user action were: ethanol concentration = 54%, cycles =66, cassettes =9117 and days = 40.Although the user affirmed in the instrument software that the ethanol concentration in bottle 6 (ethanol) was to be set to the default value of 100% at 19:58pm on (b)(6) 2019, the actual ethanol concentration remained unchanged 54% because the bottle had not been removed from the instrument for sufficient time to replace the reagent.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; and reagent stations of increasing concentration are used for the succeeding processing steps of the reagent group or type.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.Consequently, the reagent in bottle 6 (ethanol) was used for the final dehydration of the following protocols: the "factory 4hr xylene standard" protocol comprising one (1) cassette, which started in retort b at 19:59pm on (b)(6) 2019 and completed at 23:57pm on (b)(6) 2019; the "factory 2hr xylene standard" protocol comprising 74 cassettes, which started in retort b at 19:34pm on (b)(6) 2019 and completed at 21:44pm on (b)(6) 2019; and the "factory 2hr xylene standard" protocol comprising 22 cassettes, which started in retort a at 21:19pm on (b)(6) 2019 and completed at 23:30pm on (b)(6) 2019.The minimum final reagent concentration required for ethanol is 98%.The consequences of using reagent at a concentration less than the minimum required for the final dehydration and clearing steps 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 reagent in bottle 6 (ethanol) was replaced and the station properties were reset at 13:43pm on (b)(6) 2020.There is no evidence of a use error(s) in the interaction between the user and the instrument during replacement of this reagent on (b)(6) 2020.The discrepancy between the measured and calculated ethanol concentration in bottles 7 and 8 did not either cause or contribute to the sub-optimal tissue processing reported because the reagent in bottle 7 with a measured concentration of 93.5%; and bottle 8 with a measured concentration of 86% was either used for the second, third or fourth dehydration steps respectively of the "factory 4hr xylene standard" protocol started in retort b at 19:59pm on (b)(6) 2019; the "factory 2hr xylene standard" protocol started in retort b at 19:34pm on (b)(6) 2019; and the "factory 2hr xylene standard" protocol started in retort a at 21:19pm on (b)(6) 2019.The reagent in bottle 7 have been used for 44 and bottle 8 have been used for 55 previous processing runs without reported incident.

Event Description

Leica biosystems received a complaint of "under processed tissue", following completion of processing.The leica senior service engineer documented the following information reported by the complainant: "user called that he was running a test run and needed assistance with run failed error 1001 bottle 3 retort b.The reason he was running a test run was because the previous run had completed with under processed tissues.The test run had failed with insufficient reagent volume (per user) and he filled it and wanted assistance to restart the test run." on (b)(6) 2020, a leica senior applications specialist - core histology, east (fss) visited the customer site, in order to investigate the circumstances involved in this complaint and to provide applications support.The fss documented the following observations: "no error messages.All dehydrants measured were close to concentration in software.No paraffin bath contamination.Dirtiest xylene appeared to be very dirty and contain some water.No contamination in formalin or cleaning reagents." the fss reviews the logs and noted "it appears someone changed the contents in bottle 6, the tissue in question was run on the subsequent processing runs, then the contents of bottle 6 were replaced again on (b)(6) 2020.Bottle pull for initial reagent change was only 8 seconds." the fss measured the ethanol concentration in bottles 3-10 inclusive using a hydrometer.The variance between the measured ethanol concentration and that calculated by the instrument software was acceptable except for bottles 7 and 8.The measured ethanol concentration in bottles 7 and 8 was 93.5% and 86% respectively and that calculated by instrument software based on user data input was 87.7% and 75% respectively.On 21 january 2020, leica biosystems melbourne received information from the leica applications specialist-core histology that not all cases involved in this event were diagnosable; re-biopsy has been recommended; of the 96 blocks, number needing re-biopsy is currently unknown; and re-biopsy has not been performed.Information as to the final status of the tissue samples exhibiting sub-optimal processing and the patient outcome has not been provided as at (b)(6) 2020, despite the following requests for this information being made by the leica application specialist - core histology: (b)(6) 2020 during site visit; 06 january 2020 by email and telephone; and 10 january 2020 by telephone.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, 3149 ; AS 3149
• MDR Report Key: 9645654
• MDR Text Key: 190799796
• Report Number: 8020030-2020-00005
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other