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

Model Number PELORIS II

Device Problem Application Program Problem: Parameter Calculation Error (1449)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided, the tissue samples exhibiting sub-optimal tissue processing are derived from the "12 hr - autopsy" protocol comprising 82 cassettes, which started in retort a at 12:58pm on (b)(6) 2019 and failed at 22:28pm on (b)(6) 2019 during step 10 (final clearing step) of the protocol.Investigation of this complaint found that processing of tissue samples in "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 was delayed because the condensate bottle was not in contact with the corresponding sensor for approximately seven (7) hours between 15:21pm and 22:28pm on (b)(6) 2019, which resulted in pausing of the protocol.The tissue samples in retort a remained covered with 94.2% ethanol from bottle 10 until the connection between the condensate bottle and the corresponding sensor was re-established at 22:17pm on (b)(6) 2019.Steps 5 to 10 of the "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 were executed between 22:18pm and 22:28pm on (b)(6) 2019 at a reduced duration, in an attempt to meet the end time calculated by the software scheduler.The reduced duration of these processing steps did not allow sufficient time to adequately heat the retort manifold for wax transfer resulting in failure of "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019.Details of the regimen used to complete processing of these tissue samples was not provided.The root cause of the sub-optimal tissue processing reported by the complainant was that steps 5-10 of the "12 hr - autopsy" protocol started in retort a at 12:58pm on (b)(6) 2019 were executed between 22:18pm and 22:28pm on (b)(6) 2019 with a markedly reduced duration, in order to meet the end time calculated by the software scheduler, when the protocol paused for approximately seven (7) hours because the condensate bottle had moved out of contact with the corresponding sensor.The root cause of the condensate bottle moving out of contact with the corresponding sensor could not be unequivocally determined from the information available.

Event Description

Leica biosystems received a complaint of "over processed tissue", which occurred on "sunday night" following completion of processing.The complainant advised that four (4) blocks were affected; and tissue processed in wax on the same instrument.On 03 january 2020, the leica senior applications specialist-core histology received the following information from the complainant: "these tissues were dry to the point of falling off the slides during staining.Customer then retrieved additional tissue from their autopsy storage and processed those tissues in place of the original samples.They were able to diagnose these new samples." on 09 january 2020, leica biosystems (b)(4) received further information from the leica senior applications specialist-core histology that: "it turns out that this was a prostatectomy the decided to run on their autopsy run and not autopsy tissue.All of the prostate gland was submitted, but only partially grossed.So, they pulled from that sample and diagnosed from that.However, they said they are waiting for more info to determine whether the margins will have any impact on further patient care.".

• 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: 9614452
• MDR Text Key: 196284489
• Report Number: 8020030-2020-00004
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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: 12/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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