MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS 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 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided, the tissue samples exhibiting sub-optimal tissue processing are derived from the "e.12 hour - large" protocol comprising 131 cassettes, which started in retort b at 22:58pm on 08 march 2019 and failed at 06:26am on 11 march 2019 during step 10, which is the third clearing step of the protocol; and the "e.12 hour - large" protocol comprising 283 cassettes, which started in retort a at 23:05pm on 08 march 2019 and completed at 06:26am on 11 march 2019.Investigation of this complaint found that processing of tissue samples in both the affected protocols was delayed because the condensate bottle was not in contact with the corresponding sensor, which resulted in pausing of both protocols for approximately nine (9) hours and 50 minutes between 20:21pm on 10 march 2019 and 05:51am on 11 march 2019, until a user reinserted the condensate bottle.Steps 2 to 10 of the "e.12 hour - large" protocol started in retort b at 22:58pm on 08 march 2019 were executed between 05:51am and 06:26am on 11 march 2016 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 at the first wax infiltration step.Steps 6 to 13 of the "e.12 hour - large" protocol started in retort a at 23:05pm on 08 march 2019 were also executed between 05:51am and 06:26am on 11 march 2016 at a reduced duration in an attempt to meet the end time calculated by the software scheduler.The root cause of the condensate bottle moving out of contact with the corresponding sensor cannot be unequivocally determined from the information available.The root cause of the sub-optimal tissue processing reported by the complainant from the "e.12 hour - large" protocol started in retort b at 22:58pm on 08 march 2019 was insufficient dehydration and clearing of the tissue samples involved as a consequence of the eight (8) processing steps completed being executed in 34 minutes in an attempt to meet the end time calculated by the software scheduler.The root cause of the sub-optimal tissue processing reported by the complainant from the "e.12 hour - large" protocol started in retort a at 23:05pm on 08 march 2019 was insufficient dehydration, clearing and wax infiltration of the tissue samples involved as a consequence of the seven (7) processing steps completed being executed in 34 minutes in an attempt to meet the end time calculated by the software scheduler.

Event Description

Leica biosystems received a complaint that "tissue was not hydrated and wax will not stick to it and sections cannot be cut" following processing.The complainant reported that no error codes had been displayed for retort a; event code "1001" had been recorded for retort b; the condensate bottle was not pushed into the instrument far enough; all reagents were correct and the alcohols were the correct percentage.On 21 march 2019, leica biosystems melbourne received the following information from the leica senior field service technician (fse): ".All tissues were diagnosed.Since it had to be reprocessed, the processing quality wasn't good".

• Brand Name: PELORIS TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 8481394
• MDR Text Key: 148628328
• Report Number: 8020030-2019-00011
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2013
• 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