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 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided by the complainant that a user had replaced the contents of a reagent bottle with 70% ethanol and reset the reagent concentration to the default value of 100%, it has been inferred that the root cause of the sub-optimal tissue processing reported was a use error, which likely occurred at 12:51pm on (b)(6) 2019 during replacement of the reagent in bottle 6 (ethanol).The available information suggests that manual replacement of the reagent in bottle 6 (ethanol) was not completed 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: the most recent instance of reagent replacement prior to (b)(6) 2019 involved bottles 3, 5 and 6, which are designated as "ethanol".Bottles 3 (ethanol), 5 (ethanol) and 6 (ethanol) were each removed from the instrument for sufficient time to replace the contents on (b)(6) 2019.A user reset the station properties for bottles 3 (ethanol), 5 (ethanol) and 6 (ethanol) at 12:51pm on (b)(6) 2019, affirming in the instrument software that the ethanol concentration in bottle 3 was to be set to 69%; the ethanol concentration in bottle 5 was to be set to 79% and the ethanol concentration in bottle 6 was to be set to the default concentration of 100%.A total of seven (7) processing runs comprising four (4), six (6) and eight (8) hour protocols with a total of (b)(4) cassettes either started or completed between (b)(6) 2019.There was no two (2) hour protocol executed during this period.The reagent from bottle 3 (ethanol) was used for the first dehydration step; the reagent from bottle 5 (ethanol) was used for the second dehydration step and the reagent from bottle 6 was used for the final dehydration step of each of these seven (7) protocols.A further 11 processing runs comprising a total of (b)(4) cassettes were executed between (b)(6) 2019.Although the complainant did not specify the reagent bottle containing 70% which had been reset as 100% in error, evaluation of the instrument logs suggests that bottle 6 (ethanol) was subject to the use error.This finding is inferred from the fact that bottle 6 (ethanol) was the only bottle reset to 100% in the period immediately prior to the sub-optimal tissue processing reported by the complainant to have occurred on or around (b)(6) 2019.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), which likely contained 70% ethanol based on the information provided by the complainant, was used for the final dehydration step in each of the seven (7) protocols either started or completed between (b)(6) 2019 comprising (b)(4) cassettes.The minimum ethanol concentration required for use in the final dehydration step in a protocol is 98%.Using ethanol less than the minimum concentration 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 complainant did not specifically identify the processing run from which sub-optimal tissue processing was reported; but alluded to the tissue samples exhibiting sub-optimal processing being derived from a two (2) hour protocol, which either started or completed at approximately 12am on 08 november 2019.Although not reported by the complainant, it is considered likely based on the use error involving incorrect completion of manual reagent replacement in a bottle reported by the complainant and inferred from the information to be bottle 6 (ethanol), that the quality of tissue processing from each of the seven (7) processing runs executed between (b)(6) 2019 would have been adversely impacted.Similarly, the quality of tissue processing from the 11 runs executed between (b)(6) 2019 would likely also be adversely impacted by the use reagents contaminated because of the use error involving bottle 6 (ethanol).

Event Description

A leica applications specialist-core histology documented the following complaint: "the customer informed me that they had poor processing due to an incorrect bottle change by a technician.This resulting in underprocessing and poor wax infiltration." on (b)(6) 2019, a leica applications specialist-core histology (fss) visited the laboratory to investigate the circumstances involved in this complaint and to provide applications support.The fss documented the following information: "customer reported underprocessing described as 'slimy, wouldn't stick to paraffin, underprocessed, with little to no wax infiltration' sometime on or around (b)(6) 2019.They stated it was a 2hr run around midnight, yet i cannot locate in the logs.They reprocessed and reported that they believe the tissue was diagnosable.They reported this multiple weeks after the event, and attributed it to a tech placing 70% on the instrument and resetting the bottle to default (100%)." the fss also documented that the tissue samples exhibiting sub-optimal processing were derived from a two (2) hour protocol, which either started or completed at approximately 12am on (b)(6) 2019.On (b)(6) 2019, the leica applications specialist-core histology received the following information from the complainant: "they were able to reprocess and they believe the tissue was 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: 9533163
• MDR Text Key: 214564966
• Report Number: 8020030-2019-00063
• 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

• Date FDA Received: 12/30/2019
• 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: 26.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2005
• 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