MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS RAPID 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 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

Sub-optimal tissue processing was identified from the following two (2) protocols: the "gi 1hr" protocol comprising 34 cassettes was started in retort b at 12:39pm on (b)(6) 2019 and completed at 13:56pm on (b)(6) 2019; and the "gi 1hr" protocol comprising eight (8) cassettes started in retort a at 11:18am on (b)(6) 2019 and completed at 12:35pm on (b)(6) 2019.The instrument functioned as designed when processing of tissue samples from the "gi 1hr" protocol started in retort b at 12:39pm on (b)(6) 2019 was paused intermittently between 12:43pm on (b)(6) 2019 to 13:05pm on (b)(6) 2019 because the condensate bottle was intermittently not in contact with the corresponding sensor during this period.Steps 2 to 13 of the gi 1hr" protocol started in retort b at 12:39pm on (b)(6) 2019 were subsequently completed between 13:07pm and 13:56pm on (b)(6) 2019 at a reduced duration in order 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 "gi 1hr" protocol started in retort b at 12:39pm on (b)(6) 2019 was insufficient dehydration and clearing of the tissue samples involved as a consequence of the 12 remaining processing steps being executed in 49 minutes 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 could not be unequivocally determined from the information available the instrument operated within specification during execution of the "gi 1hr" protocol started in retort a at 11:18am on (b)(6) 2019.The root cause of the sub-optimal tissue processing reported by the complainant from the "gi 1hr" protocol started in retort a at 11:18am on (b)(6) 2019 could not be determined from the information available.

Event Description

On (b)(6) 2019, leica biosystems received a complaint detailing the following: "wax changed in wax 1 on apr 16, still at 100% but has been used several times since, doesn't think processor is counting concentration correctly.Should have degraded to 98 by now.Just changes wax 3 which was at 92% but wax solidifying incompletely (slimy with added carry over solvent?)" on (b)(6) 2019, a leica field service engineer (fse) visited the customer site in relation to the customer complaint regarding wax degradation.The fse documented the following: "in addition, tissue was underprocessed on run made on (b)(6) at 12:26." on (b)(6) 2019, a leica applications specialist-core histology (fss) telephoned the complainant and documented the following: "two short gi ihr protocols-one on (b)(6) and one on (b)(6)-ended with some of the larger fatty specimens appearing squishy and exploded when they were placed on the water bath.Appeared underprocessed.On (b)(6) at 12:26 a protocol was run on retort that left the specimens squishy, i.E, not dehydrated.The customer reported that after the protocol they checked reagent container 11 (xylene) which did not smell very much like xylene.They replaced the reagent immediately, before leica rep could check." the fss also documented that the customer reported that the condensate bottle caused a warning message to be displayed even though the bottle was properly inserted.On (b)(6) 2019, the fss received information that all cases involved in this event were diagnosable.(this information was received by leica biosystems (b)(4) on 09 may 2019.).

• 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: 8656979
• MDR Text Key: 209394958
• Report Number: 8020030-2019-00019
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2010
• 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