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

Model Number PELORIS II

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/08/2015

Event Type  Injury  

Event Description

Leica biosystems received a complaint regarding sub-optimal processing of 30 specimens, which had been processed using either an eight (8) hours protocol in retort a or a 12 hour protocol in retort b.The complainant advised that the protocols from which sub-optimal tissue processing had been identified started on (b)(6) 2015 and completed on (b)(6) 2015.The complainant also advised that the pump hours were 2304; and that preventive maintenance has never been performed.On (b)(6) 2015, a leica field support specialist (fss) provided technical support by telephone in association with this complaint.The complainant advised that the affected tissue types comprised skin, gastro-intestinal and lipoma samples; and described the affected tissue samples from the eight (8) hour protocol as "fried" and those from the 12 hour protocol as "not processed".The complainant also advised that: "some tissues were resubmitted (extra).There are specimen that cannot be re-collected".Multiple attempts to obtain info from the complainant were made by both telephone and email between (b)(6) 2015 and (b)(6) 2015 without success, with the exception of (b)(6)2015.On (b)(6) 2015, the fss requested further detail from the complainant regarding the affected tissue samples and was advised only that: "there are specimen not diagnosed" and that he "does not have time to discuss this" in response to a query as to number of cassettes involved.

Manufacturer Narrative

Site access for a leica rep to this facility, which is located on a military base, was not provided.Instrument logs are not available for eval, because the complaint is not permitted to download the info.

Manufacturer Narrative

Evaluation of the instrument logs found that bottle 4 (ethanol) was removed from the instrument at 13:47pm on (b)(6) 2015 for 4 seconds, which is not sufficient time to complete manual replacement of the reagent; and the properties of the corresponding reagent station were reset.Resetting the reagent station set the concentration to the default value configured in the reagent types definitions (100% in this instance); and reset the number of cassettes processed and the number of cycles and days to zero.Since the user has set bottle 4 (ethanol) at 13:47pm on (b)(6) 2015, this reagent would have been scheduled for the final dehydration step of the "factory 12hr xylene standard" protocol started in retort b at 07:28am on (b)(6) 2015 and the "factory 8hr xylene standard" protocol started in retort a at 07:34am on (b)(6) 2015, from which sub-optimal tissue processing was reported.Although the user affirmed in the instrument software that the concentration in bottle 4 (ethanol) was reset to 100% at 13:47pm on (b)(6) 2015, the actual concentration of the reagent in bottle 4 remained unchanged at 50.2% because the reagent had not been replaced.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 subsequent processing steps ultimately resulting in sub-optimal processing.The root cause for the sub-optimal tissue processing reported was a use error, which occurred prior to commencement of the affected protocols, and involved failure by the user to complete the manual reagent replacement process in accordance with the manufacturer instructions detailed in the leica peloris/peloris ll user manual.

Event Description

This hospital is located on a secure military base and authorization for a (b)(4) representative to attend the site was not provided until on (b)(4) 2015.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn rd.; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley, victoria 3149 ; 92117535
• MDR Report Key: 4911478
• MDR Text Key: 6011437
• Report Number: 8020030-2015-00066
• 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,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention