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 Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The root cause of the sub-optimal tissue processing reported was a use error, which occurred between 10:44am and 10:47am on (b)(6) 2019, as evidenced by information documented by the local applications specialist during a visit to the customer site.Specifically, the measured ethanol concentration in bottle 5 was 75%, and that calculated by the instrument software was 100%.The facts suggest that a user failed complete manual replacement of the reagent in bottle 5 (ethanol) in accordance with the manufacturer instructions detailed in the leica peloris/peloris ll user manual, which 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 bottle 5 (ethanol) was not in contact with the corresponding sensor for approximately 3 minutes and 05 seconds from 10:44am on 27 november 2019, which is sufficient time to replace the reagent.The station properties were reset at 10:47am on 27 november 2019, with a user affirming in the instrument software that the ethanol concentration in bottle 5 was to be set to the default concentration of 100%.The properties of the reagent bottle in 5 prior to this user action were: ethanol concentration=74.7%, cycle=18, cassettes=545 and days=19.Although a user affirmed in the instrument software that the reagent concentration in bottle 5 (ethanol) was to be set to the default value of 100% at 10:44am on 27 november 2019, the measured ethanol concentration of 75% on 04 december 2019 indicates that a use error occurred during replacement of this 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 5 (ethanol) was used for the final dehydration step of the "factory 8hr xylene standard 2" protocol comprising 29 cassettes, which started in retort b at 19:43pm on 27 november 2019, and completed at 04:00am on 29 november 2019, and the "factory 2hr xylene standard" protocol comprising 34 cassettes, which started in retort a at 19:44pm on 27 november 2019, and completed at 04:00am on 29 november 2019, from which sub-optimal tissue processing was identified by the complainant.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 discrepancy between the measured and calculated ethanol concentration in bottles 6 (ethanol), and 10 did not either cause or contribute to the sub-optimal tissue processing reported because the reagent in bottle 6 with a measured concentration of 85% and the reagent in bottle 10 with a measured concentration of 90% was used for the second and third dehydration steps respectively of the "factory 8hr xylene standard 2" protocol started in retort b at 19:43pm on 27 november 2019, and the "factory 2hr xylene standard" protocol started in retort a at 19:44pm on 27 november 2019, from which sub-optimal tissue processing was identified by the complainant.The reagent in bottles 6 and 10 had been used for 18 previous processing runs without reported incident; and information recorded in the instrument logs in association with reagent replacement performed 08 november 2019 does not show evidence of any use error(s) in replacing reagents during this period.

Event Description

Leica biosystems received a complaint of "under process tissue" and "contaminated reagent noted".The complainant advised that approximately 30-40 blocks were affected; and no error codes had been displayed.On 04 december 2019, a leica application specialist, core histology (fss), visited the customer site in order to provide applications support.The fss measured the ethanol concentration in bottles 3-10 inclusive using a hydrometer; and found that the variance between the measured ethanol concentration and that calculated by the instrument software exceeded the acceptable limits for bottles 5, 6, and 10.The measured ethanol concentration in bottles 5, 6 and 10 was 75%, 85%, and 90% respectively; and that calculated by the instrument software was 100%, 78%, and 79% respectively.On 19 december 2019, the leica applications specialist-core histology received information that all cases involved in this event were diagnosable.

• 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: 9533693
• MDR Text Key: 216648549
• Report Number: 8020030-2019-00064
• 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: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2011
• 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