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

Model Number PELORIS

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided by the complainant, error code "1337" occurred during the "fat tissue or eye" protocol comprising 143 cassettes, which started in retort b at 20:16pm on (b)(6) 2017 and failed at 22:43pm on (b)(6) 2017.Manufacturer evaluation of the instrument logs showed that both the local and remote alarms were activated when the "fat tissue or eye" protocol started in retort b at 20:16pm on (b)(6) 2017, failed at 22:43pm on (b)(6) 2017; the cassettes remained in retort covered b with ethanol at a concentration of 92.6% at the two (2) basket fill level for approximately 49 minutes until a user intervened at 23:32pm on (b)(6) 2017 and the instrument was not restarted.It was also identified that error code "1337" had been recorded on (b)(6) 2017, (b)(6) 2017 and (b)(6) 2017.In each of these three (3) instances error code "1337 was both preceded and succeeded by other event codes indicative of sub-optimal performance of internal power elements in the instrument, for which the root cause(s) could not be unequivocally ascertained from the information available.It was also identified that in each of these three (3) instances the instrument had been re-started and used to process further tissue samples.Although no adverse impact on the quality of tissue processing has been reported to leica biosystems in association with any of these three (3) previous instances, the user action in re-starting the instrument is in direct contravention to the information displayed stating not to use the instrument and to contact service; and constitutes a use error which has previously resulted in a serious injury.Investigation of this complaint found that the instrument functioned as designed when the "fat tissue or eye" protocol started in retort b at 20:16pm on (b)(6) 2017, failed at 22:43pm on (b)(6) 2017 as a consequence of a sudden, unexpected drop in the retort wax line temperature.The root cause of the reported error code "1337", which indicates a sudden unexpected drop in the retort wax line temperature and caused the "fat tissue or eye" protocol started in retort b at 20:16 on (b)(6) 2017 to fail at 22:43 on (b)(6) 2017, could not be unequivocally determined from the information available.

Event Description

Leica biosystems received a complaint that error code "1337 had been displayed during a processing run in progress in retort b.The following information would have been displayed to the user in association with this error code: "retort wax valve leaking.Do not use instrument; contact service, retort b." a leica north america technical support center representative documented the following: "caller not aware of any impact on tissue." leica representatives visited the laboratory on 19, 20 and 21 september 2017, in order to assess the operation and function of the instrument.On 20 september 2017, leica biosystems melbourne received information that tissue samples involved in this complaint were diagnosable.

• 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, victoria 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 6957274
• MDR Text Key: 89569667
• Report Number: 8020030-2017-00074
• 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: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2007
• 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