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

Model Number PELORIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/08/2019

Event Type  Injury  

Manufacturer Narrative

The root cause of the sub-optimal tissue processing identified by the complainant could not be unequivocally determined from the information available.However, the combination of a prolonged fixation step at 55 °c, clearing and infiltration steps at temperatures higher than recommended by the manufacturer may have contributed to the sub-optimal tissue processing reported.Manufacturer evaluation of the instrument logs indicates that the tissue samples involved in this event were derived from the "breast & fatty tissue programme" protocol comprising 204 cassettes, which started in retort b at 16:13pm on (b)(6) 2019 and completed at 07:37am on (b)(6) 2019; and the "renal transplant & ultras 2.5 hrs" protocol comprising 108 cassettes, which started in retort a at 16:25pm on (b)(6) 2019 and completed at 07:00am on (b)(6) 2019.No use error(s) was identified in the interaction between the user and the instrument either prior to, or during execution of the "breast & fatty tissue programme" protocol started in retort b at 16:13pm on (b)(6) 2019; and the "renal transplant & ultras 2.5 hrs" protocol started in retort a at 16:25pm on (b)(6) 2019, from which sub-optimal tissue processing was identified.Configuration of the "renal transplant & ultras 2.5 hrs" protocol is similar, but not identical, to the manufacturer recommended two (2) hour protocol.The laboratory has customized the protocol such that the formalin step is at 55°c rather than the manufacturer recommended ambient temperature; the first two (2) xylene steps are at 55°c rather than the manufacturer recommended ambient temperature; and the first two (2) wax infiltration steps are at 77°c rather than the manufacturer recommended 65°c.This protocol was validated by the laboratory on 05 january 2017.Investigation of this complaint found that the instrument operated within specification between (b)(6) 2019.

Event Description

Leica biosystems received a complaint that: "retort a failed on a process again".On 12 november 2019, leica biosystems (b)(4) received the following information from the leica northern team leader (b)(4): "i'm just picking up on this mail as the customer has asked for support on this following this 2nd pmdr in approx.3 weeks.There has been lost t." on 13 november 2019, leica biosystems (b)(4) received the following from the leica northern team leader (b)(4): "also, i noticed i missed a chunk of the sentence i wrote on the email earlier from the first paragraph, but it was a copy from the customers email to me on the severity of the issue for them/us: this situation will now lead to a serious harm review as we have multiple biopsies that have been rendered undiagnosable." on 18 november 2019, leica biosystems (b)(4) received the following information documented by the quality risk and governance manager for the institution in relation to patient outcome: "cases came off processor with loss of nuclear detail.Reprocessing was attempted on some of the blocks with no success.Some of the blocks have been restained with a method recommended by field support scientist which showed improvement but pathologist still could not make a diagnosis.I know of at least two cases which the patients have already been rebiopsied, there is at least 13 cases which are thought to be undiagnosable the full details are still coming in.I can provide more details as i get them." on 29 november 2019, leica biosystems (b)(4) received the following information from the leica field support scientist - (b)(4): "i have received the following information from (b)(4): 'as for numbers of cases affected as of last night the numbers are: total of 76 cases processed (b)(6) in retort 1a and 1b: 45 cases no harm.9 cases awaiting report.22 cases harm affected to varying degrees - level of harm to be determined.For example some patients are returning for re-biopsy, others require closer follow up or additional imaging etc.(b)(6) submitted for: total of 9 cases bowel screening programme.Total of 5 colposcopy cases cervical screening programme' i don't have any identifier details yet but am hoping to have a meeting with them next week so will request it then.Hopefully all will be complete then." on 05 december 2019, the leica field support scientist - (b)(4) received the following information from the complainant in relation to the patient outcome: 76 cases in processor on (b)(6).49 cases considered no harm - 2 are bowel screening programme so they may decide to upgrade these to harm when reviewed week beginning (b)(6).8 cases awaiting report - level of harm to be determined on reporting.19 cases affected and harm being determined: 2 patient will have increased follow up.1 patient underwent fna in place of re-biopsy and will have further observation.2 patients have undergone or will undergo re-biopsy and further impact on patient pathway being determined.5 colposcopy cases re-biopsy required, cervical screening programmed (b)(6) raised.7 bowel screening cases, (b)(6) raised, clinical impact being determined by dr (b)(6) (week beginning (b)(6)).2 further cases outcome / change to pathway to be determined.In total so far 8 patients have or will undergo a further procedure for example repeat biopsy.I'll send the initials, dob gender info tomorrow.On 10 december 2019, leica biosystems (b)(4) received the following information from the field support scientist - (b)(4), which was provided by the laboratory: "sorry i haven't provided you with the details of the initials, dob and gender.We needed to run this past our information governance team and they haven't responded yet.".

• 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: 9448948
• MDR Text Key: 186375051
• Report Number: 8020030-2019-00053
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2007
• 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
• Patient Outcome(s): Required Intervention