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

Model Number PELORIS

Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2016

Event Type  malfunction  

Event Description

Leica biosystems received a complaint regarding sub-optimal processing of approximately 130 blocks in retort a.On (b)(6) 2016, leica biosystems received information that all tissue samples exhibiting sub-optimal processing were diagnosable.

Manufacturer Narrative

Investigation if this complaint by leica biosystems remains in progress.

Manufacturer Narrative

Investigation of this complaint found that the instrument operated within specification during execution of the "7hour" protocol, which started in retort a at 21:02 pm on (b)(4) 2016 and completed successfully at 07:45am on (b)(4) 2016, from which sub-optimal tissue processing was reported by the complainant.The root cause of the sub-optimal tissue processing reported was the combined use of ethanol from bottle 9 at a concentration of 80.2% for the fifth of the six dehydration steps in the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016; and ethanol from bottle 7 at a concentration of 70% for the final dehydration step in the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016.The minimum final reagent concentration required for ethanol is 98%.The consequences of using ethanol at a concentration less than the minimum required for the final dehydration step in a protocol is re-introduction of water into the tissue which cannot be displaced in subsequent processing steps; and contamination of reagents used in the subsequent processing steps, ultimately resulting in sub-optimal tissue processing.Although bottles 7 and 9 are designated as , bottles 7 and 9 were filled with 70% and 80% ethanol respectively on (b)(4) 2016 as detailed in mfr.Report# 8020030-2016-00041, which has been submitted previously.The root cause for bottles 9 and 7 being used for the penultimate and final dehydration steps of the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016 was a combination of the reagent management being set as .Reagents initially scheduled for use in the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016 had already been scheduled for a protocol which started in retort b prior to commencement of the protocol in retort a.As a consequence of the lack of availability of the reagent in bottles 5 and 4 initially scheduled for use in the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016, the instrument functioned as designed by allocating an alternative reagent with the lowest number of cycles for both the penultimate and final dehydration steps of the "7hour" protocol started in retort a at 21:02 pm on (b)(4) 2016, which was bottle 9 and 7 respectively.

• 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, victoria 3149 ; AS 3149 ; 92117535
• MDR Report Key: 5920043
• MDR Text Key: 54410600
• Report Number: 8020030-2016-00047
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• 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?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1