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

Model Number PELORIS

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

The sub-optimal tissue processing reported by the complainant is derived from the "2 hour biopsy" protocol started in retort b at 17:49 pm on (b)(6) 2017, which completed successfully at 03:00 am on (b)(6) 2017.Investigation of this complaint found that the instrument functioned as designed during execution of the "9.5 hour large tissue" protocol started in retort a at 18:24 pm and the "2 hour biopsy" protocol started in retort b at 18:25 pm on (b)(6) 2017, as a consequence of a leaking retort a wax valve.The user actions in response to the "1337" error code generated by the sudden, unexpected drop in the retort wax line temperature caused by the leaking retort a wax valve were in accordance with the information displayed on the instrument monitor, which is not to use the instrument and to contact service.The instrument functioned within specification during execution of the "2 hour biopsy" protocol started in retort b at 17:49 pm on (b)(6) 2017, from which sub-optimal tissue processing was reported by the complainant on (b)(6) 2017.The root cause of the sub-optimal tissue processing reported by the complainant is the use of formalin contaminated wax for the wax infiltration step of the protocol.The root cause of the wax contamination with formalin was failure of the fse to complete on (b)(6) 2017 all steps of the manufacturer specified regimen for troubleshooting the "1337" error code, which had been generated at 18:26 pm on (b)(6) 2017 for retort a and indicated a leaking retort wax valve.Section 6.6 technical service bulletin (tsb) b26.5066.680 peloris error 1337 troubleshooting stipulates that the least concentrated wax is drained through a retort and that both retort wax lines are subsequently cleaned prior to returning to clinical use.In this instance, they do not show any evidence that the wax in any of the four (4) wax chambers had been replaced.As a consequence, any reagent (including formalin) contamination remaining in the retort a wax line would have been drawn into the retort during execution of the wax step in subsequent processing runs; which would in turn result in water being re-introduced into tissue samples during wax infiltration and the sub-optimal tissue processing reported.

Event Description

Leica biosystems received a complaint that "water in paraffin" following completion of the routine biopsy 2 hour protocol.The complainant advised that 70 biopsies may have been affected.On 18 may 2017, leica biosystems received information that all tissue samples exhibiting sub-optimal tissue processing were diagnosable.On 01 may 2017, a leica field service engineer (fse), attended the laboratory in response to a complaint (service order: (b)(4)) regarding display of error code "1337", which indicates a leaking retort wax valve, and the associated information displayed not to use the instrument and to contact service.The fse documented that performance tests were conducted; the wax valve for retort a was re-built and technical service bulletin (tsb) b26.5066.680 peloris error 1337 troubleshooting has been applied.The fse also documented that the complainant confirmed that no tissue sample(s) had been adversely affected as a consequence of the circumstances involved.On 05 may 2017, the fse returned to the laboratory in response to this compliant.The fse documented that the retort wax valve on retort b was replaced and technical service bulletin (tsb) b26.5066.680 peloris error 1337 troubleshooting has been applied.

• 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 ; 92117535
• MDR Report Key: 6603942
• MDR Text Key: 76408866
• Report Number: 8020030-2017-00031
• 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: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• 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: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2009
• 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