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

Model Number PELORIS II

Device Problems Application Program Problem: Parameter Calculation Error (1449); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation of the instrument logs showed that the "twelve hr fixed brain" protocol comprising 42 cassettes and started in retort a at 17:58pm on (b)(6) 2018 failed at 06:24am on (b)(6) 2018 during step 10, which was the third clearing step of the protocol.Although not reported by the complainant, the "2hr small - med" protocol comprising 16 cassettes and started in retort b at 18:02pm on (b)(6) 2018 failed at 06:41am on (b)(6) 2018 during step 10, which was the third clearing step of the protocol.Investigation of this complaint found that processing of tissue samples in both the "twelve hr fixed brain" protocol started in retort a at 17:58pm on (b)(6) 2018 and the "2hr small - med" protocol started in retort b at 18:02pm on (b)(6) 2018 was delayed because the condensate bottle was not in contact with the corresponding sensor, which resulted in pausing of both protocols.The root cause of the condensate bottle not being detected by the corresponding sensor was that the upper coupler was not properly seated in the reagent cabinet due to tubing interfering with the coupler.The root cause of tubing interfering with the position of the coupler could not be determined from the information available.The root cause of the sub-optimal tissue processing reported by the complainant was the occurrence of event code "13 - condensate bottle is not present, insert bottle to continue", which caused both the "twelve hr fixed brain" protocol started in retort a at 17:58pm on (b)(6) 2018 and the "2hr small - med" protocol started in retort b at 18:02pm on (b)(6) 2018 to pause for approximately 11 hours.Although the tissue samples in retort b remained covered with formalin during the paused protocol, the tissue samples in retort a were not covered with reagent, which would have contributed to the sub-optimal tissue processing reported by the complainant.Steps 5 to 10 of the "twelve hr fixed brain" protocol started in retort a at 17:58pm on (b)(6) 2018 and steps 2 to 10 of the "2hr small - med" protocol started in retort b at 18:02pm on (b)(6) 2018 were executed between at 06:11am and 06:24am on (b)(6) 2018 at a reduced duration in an attempt to meet the end time calculated by the software scheduler.The reduced duration of the processing steps in both protocols did not allow insufficient time to adequately heat the retort manifold for wax transfer resulting in failure of both the "twelve hr fixed brain" protocol started in retort a at 17:58pm on (b)(6) 2018 and the "2hr small - med" protocol started in retort b at 18:02pm on (b)(6) 2018 at the final clearing step.Details of the regimen used to continue processing of the tissue samples from the abandoned protocols are not available.

Event Description

Leica biosystems received a complaint of dry, brittle, over-processed tissue from a processing run comprising "60 blocks", which had been executed in retort b.The complainant advised that processing run had stopped in the alcohol step, resumed than failed in the last xylene step; and an error(s) associated with the heater manifold on retort b was displayed.On (b)(6) 2018, a leica field applications specialist (fss) provided telephone support to the laboratory in order to obtain further information regarding the circumstances involved in this complaint.The fss documented that the condensate bottle appeared to have been "tripped on/off from 19:55pm on (b)(6) until 06:11am on (b)(6) " while reagent from bottle 5 (ethanol) remained in the retort; and affected processing was the "12 hr fixed brain" protocol comprising 42 cassettes, which started in retort a at 17:58pm on (b)(6) 2018.On 08 june 2018 a leica biosystems field support engineer (fse) visited the laboratory.The fse documented that the condensate bottle "was not fitting in correctly and flush against its couplers." the upper bottle coupler was found to be not seated flush to the reagent cabinet back wall "due to 8 mm bottle vent tubing jammed between it and air manifold".This issue was resolved by moving the jammed tubing.On 15 june 2018, leica biosystems melbourne received information that all cases from which tissue samples exhibited sub-optimal processing 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, 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: 7665694
• MDR Text Key: 113507283
• Report Number: 8020030-2018-00036
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2017
• 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