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 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The root cause of the sub-optimal tissue processing reported was a use error, which occurred at 18:41pm on (b)(6) 2019, when a user failed to complete manual replacement of the reagent in bottle 8 (ethanol) in accordance with the manufacturer instructions detailed in the leica peloris/peloris ll user manual specifically, the leica applications specialist (fss) documented the following information provided by the complainant that: ".Bottle 8 changed with 70% but marked changed as 100% (occurred overnight between (b)(6)).".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 shows that bottle 8 (ethanol) was not in contact with the corresponding sensor for the following periods on (b)(6) 2019 prior to execution of the processing runs from which sub-optimal tissue processing was identified by the complainant: approximately 2 minutes and 6 seconds at 18:39pm on (b)(6) 2019, which is sufficient time to replace the reagent, and the station properties were reset to 100% at 18:41pm on (b)(6) 2019; 25 seconds at 16:38pm on (b)(6) 2019, which is not sufficient time to replace the reagent, and the station properties were not changed; 38 seconds at 16:40pm on (b)(6) 2019, which is not sufficient time to replace the reagent, and the reagent concentration was set to 70% at 16:41pm on (b)(6) 2019; and 1 minute and 43 seconds at 17:26pm on (b)(6) 2019, which is sufficient time to replace the reagent, and the reagent concentration was to be set to 70% at 17:28pm on (b)(6) 2019.The properties of the reagent in bottle 8 prior to these user actions were: ethanol concentration=80.9%, cycle=60, cassettes=3027 and days=28.Although the user affirmed that the ethanol concentration in bottle 8 (ethanol) was to be set to the default value of 100% at 18:41pm on (b)(6) 2019, the information provided suggests that the reagent in bottle 8 (ethanol) had been incorrectly replaced with 70% ethanol and a user had affirmed in the instrument software that the reagent concentration was to be set to the default value of 100%.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 8 (ethanol) was used for the final dehydration step of the "factory 8hr xylene standard" protocol comprising 44 cassettes, which started in retort b at 18:51pm on (b)(6) 2019 and completed at 03:36am on (b)(6) 2018; the "factory 8hr xylene standard" protocol comprising 20 cassettes, which started in retort a at 22:59pm on (b)(6) 2019 and completed at 12:00pm on (b)(6) 2019; the "factory 1hr xylene standard" protocol comprising 12 cassettes, which started in retort a at 15:00pm on (b)(6) 2019 and completed at 16:21pm on (b)(6) 2019; and the "factory 2hr xylene standard" protocol comprising 15 cassettes, which started in retort b at 15:00pm on (b)(6) 2019 and completed at 17:23pm on (b)(6) 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.

Event Description

Leica biosystems received a complaint detailing the following in relation to tissue samples which had been processed ".Tissue, not process correctly microtomy is bad and they noticed the different tissue quality during embedding.91 blocks.Staff incorrectly change bottle 8 alcohol concentration and reprocessing of 91 blocks.Pathologist are qc'ing the slides." on (b)(6) 2019, a leica application specialist (fss) visited the customer site, in order to provide applications support.The fss documented the following information provided by the complainant: ".Bottle 8 changed with 70% but marked changed as 100% (occurred overnight between (b)(6))."; tissue in a total of 91 cassettes from four (4) processing runs comprising various tissue types of unknown size, which had been executed in either retort a or b on 21 november 2019, was adversely impacted; the affected processing runs were one (1), two (2), four (4) and eight (8) hour protocols; and reagents had already been replaced.On 24 november 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: 9501365
• MDR Text Key: 220574265
• Report Number: 8020030-2019-00060
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• 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