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

Model Number PELORIS

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Error code 1337 is generated when an unexpected, rapid drop in the wax line temperature is detected by the instrument software, likely due to a leaking retort wax valve allowing cold reagent into the line.The instrument is rendered inoperable, because the leak causes formalin contamination of the wax.The following information is displayed to the user in association with error code 1337: "retort wax valve leaking.Do not use instrument; contact service.".

Event Description

A (b)(6) representative received a complaint that error code 1337, which indicates a leaking retort wax valve, had been displayed for retort b during execution of a processing protocol and the customer had re-started the instrument.The (b)(6) representative also documented that the customer was executing a test processing run; and there was no adverse impact on tissue samples.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

The instrument logs provided to the manufacturer for evaluation on (b)(6) 2019 showed that: quick clean protocol was started in retort b at 06:49am on (b)(6) 2019.Error code "1337" was recorded at 06:51am on (b)(6) 2019 with the following information being displayed to the user: "retort wax valve leaking.Do not use instrument, contact service, retort b." the instrument was shut down by a user at 06:56am on (b)(6) 2019; and re-started at 07:00am on (b)(6) 2019.The action to re-start the instrument is not in accordance with the information displayed in association with error code "1337", which specifically states not to use the instrument and to contact service.Although numerous tissue processing protocols were executed following the incorrect user action in re-starting the instrument, the complainant has not reported any adverse impact on the quality of tissue processing.Error code 1337 is generated when an unexpected, rapid drop in the wax line temperature is detected by the instrument software.The possible causes are: 1.A leaking retort wax valve allowing cold reagent into the wax line resulting in formalin contamination of the wax.Use of formalin contaminated wax when processing tissue samples adversely impacts the quality of tissue processing.2.Issues with the heating or temperature measurement elements in the wax lines.3.Issues with the power supply to the heating and/or temperature measurement elements in the wax lines.No adverse impact on the quality of tissue processing was reported by the complainant following the incorrect user action of re-starting the instrument after display of error code 1337, which suggests that a retort wax valve was not leaking in this instance.

• 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
• MDR Report Key: 9391033
• MDR Text Key: 219765740
• Report Number: 8020030-2019-00047
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1