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 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

The root cause of the sub-optimal tissue processing reported was a use error, which occurred at 09:20am on (b)(6) 2019.The facts suggest that a user failed to correctly complete manual replacement of the reagent in bottle 7 (ethanol) as 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 7 (ethanol) was not in contact with the corresponding sensor for periods of approximately 20 seconds and eight (8) seconds between 09:19am and 09:20am on (b)(6) 2019, neither of which is for sufficient time to replace the reagent.The station properties were reset at both 09:19am on (b)(6) 2019, with a user affirming in the instrument software that the reagent concentration was to be set to 0% and at 09:20am on (b)(6) 2019, with a user affirming in the instrument software that the reagent concentration was to be set to 100%.The properties of the reagent in bottle 7 prior to these user actions were: ethanol concentration=68.1%, cycle=70, cassettes=(b)(4) and days=61.Although the user affirmed that the ethanol concentration in bottle 7 (ethanol) was to be set to the default value of 100% at 09:20am on (b)(6) 2019, the actual ethanol concentration would have remained unchanged at 68.1% 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.Following the use error at 09:20am on (b)(6) 2019, the reagent in bottle 7 (ethanol) was then used for the final dehydration step of the "routine overnight" protocol comprising (b)(4) cassettes, which started in retort a at 17:33pm on (b)(6) 2019 and completed at 04:57am on (b)(6) 2019; and the "routine overnight" protocol comprising (b)(4) cassettes, which started in retort b at 19:41pm on (b)(6) 2019 and completed at 08:00am 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.

Event Description

Leica biosystems received a complaint detailing: "valve leaking mushy tissue" following completion of processing.On (b)(6) 2019, a leica application specialist (fss) visited the customer site, in order to provide applications support.The fss documented that the documented that the tissue samples exhibiting sub-optimal processing were most likely derived from the routine overnight protocols started in retort a at 17:33pm on (b)(6) 2019 comprising 128 cassettes, and in retort b at 19:41pm on (b)(6) 2019 comprising 244 cassettes.On (b)(6) 2019, leica biosystems melbourne received information that: "tissue was reprocessed, all cases 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: 9492748
• MDR Text Key: 202421662
• Report Number: 8020030-2019-00059
• 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: 12/19/2019

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: 11/21/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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