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

Model Number PELORIS

Device Problems Incorrect Or Inadequate Test Results (2456); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  malfunction  

Event Description

Leica biosystems received a complaint that an overnight protocol in retort b on (b)(6) 2016 had failed prior to completion.The complainant advised that an error code indicating that the requested reagent station was not available was displayed in association with the failed protocol; and advised that the tissue samples from the failed processing run were compromised because the "nuclei were washed out".On 29 march 2016, leica biosystems received information that all tissue samples exhibiting sub-optimal tissue processing were diagnosable.Analysis by the manufacturer indicates that the sub-optimal processing reported was caused by the use of 84.4% ethanol in the final dehydration step of the failed "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016.The specific circumstances that led to the use of this reagent for the final dehydrating step of this protocol remain under investigation.

Manufacturer Narrative

The "factory 8hr xylene standard" protocol started in retort b at 16:42pm on (b)(6) 2016 failed at 18:37pm on (b)(6) 2016 during step 5.The instrument logs show that the retort b liquid level sensors did not activate in the expected sequence.Specifically, liquid was detected by the overflow (top) liquid level sensor before the middle and lower liquid level sensor indicating that the retort was overfull in each instance.The defined software workflow when liquid level sensors in a retort are activated in the sequence described is to substitute reagent from an alternative compatible reagent station, because the fill level in the retort from a particular reagent bottle cannot be verified by the instrument software.The protocol is abandoned in the circumstances where all available compatible reagent stations have been cycled through and activation of the top liquid level sensor before the middle liquid level sensor has recurred; and a suitable alternative is not available.The pattern of the codes recorded for the function of the liquid level sensors suggest that the failure was caused by the incorrect placement of reflective objects in the retort.Specifically, metal cassette lids or baskets may reflect light emitted from the liquid level sensor(s) when improperly positioned in the retort, which results in the presence of fluid not being detected.The instrument functioned as designed by filling retort b with the reagent from bottle 3 (ethanol), which had been used for the last successful processing step and had a concentration of 84.5%.At 18:51pm on (b)(6) 2016, a user drained the contents of retort b to bottle 3 (ethanol), which reset the software workflow.At 19:15pm on (b)(6) 2016, a user edited the "factory 8hr xylene standard" protocol to commence at step 5 (ethanol).This modified protocol comprised three (3) dehydration steps, three (3) clearing steps and three (3) wax infiltration steps.The modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016 comprising 172 cassettes based on data entered into the instrument software by the user, failed at 22:34pm on (b)(6) 2016 having completed five (5) steps of the modified protocol only.Codes recorded during execution of step 3 of the modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016 for which bottle 4 (ethanol) had been scheduled indicate that the retort b liquid level sensors did not activate in the expected sequence.In accordance with the defined software workflow, bottles 7 (ethanol), 9 (ethanol), 10 (ethanol) 8 (ethanol) and 5 (ethanol) were sequentially substituted when the retort b liquid level sensors did not activate in the expected sequence.Bottle 3 (ethanol) with a concentration of 84.4% was used for step 3, which was the final dehydration step of this modified protocol.Codes recorded during execution of step 6 of the modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016 indicate that the retort b liquid level sensors did not activate in the expected sequence; and the fill sequence for retort b could not be completed using either the scheduled reagent bottle or any of available substitute reagent bottles during subsequent retry attempts per the defined software workflow.The instrument functioned as designed by filling retort b with reagent from bottle 11 (clear-rite), which had been used for the last successful processing step and had a concentration of 97.1%, before abandoning the protocol and activating the local and remote alarms.A user drained the contents of retort b to bottle 11 (clear-rite) at 22:35pm on (b)(6) 2016, which reset the software workflow.At 22:39pm on (b)(6) 2016, a user edited the "factory 8hr xylene standard" protocol to comprise one (1) clearing step and three (3) wax infiltration steps.The modified "factory 8hr xylene standard" protocol started in retort b at 22:39pm on (b)(6) 2016 comprising 172 cassettes based on data entered into the instrument software by the user, completed successfully at 02:07am on (b)(6) 2016.Investigation of this complaint found that the instrument functioned as designed in the circumstances involved in this complaint.The root cause for failure of the both the factory 8hr xylene standard" protocol started in retort b at 16:42pm on (b)(6) 2016 and the modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016 was liquid level sensor errors.Specifically, liquid was detected by the retort b overflow (top) liquid level sensor before the middle and lower liquid level sensors; and the defined software workflow for this circumstance was implemented as designed.The root cause of the retort b liquid level sensor errors was incorrect placement of reflective objects in the retort.The root cause of the sub-optimal processing reported was the use of 84.4 % ethanol in the final dehydration step of the modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016, which failed at 22:34pm on (b)(6) 2016.The minimum final reagent concentration required for ethanol is 98%.The consequences of using ethanol at a concentration less than the minimum 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 the root cause of 84.4 % ethanol being used in the final dehydration step of the modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016 was the combination of multiple instances in which the retort b liquid level sensors were not activated in the expected sequence, which likely resulted from incorrect placement of reflective objects in the retort; and draining of retort b by a user at 18:51pm on (b)(6) 2016, which reset the software workflow.Configuration of the modified "factory 8hr xylene standard" protocol started in retort b at 22:39pm on (b)(6) 2016, which was used to continue processing of the tissue samples from the failed modified "factory 8hr xylene standard" protocol started in retort b at 19:15pm on (b)(6) 2016, resulted in insufficient dehydration of these tissue samples prior to the clearing and wax infiltration stages of processing.

• 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, victoria 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149 ; 92117535
• MDR Report Key: 5589829
• MDR Text Key: 44183063
• Report Number: 8020030-2016-00019
• 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,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2009
• 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