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

Model Number PELORIS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided, it was determined that the tissue samples involved in this event were derived from the "factory 4hr xylene standard small bigs" protocol comprising 19 cassettes, which started in retort b at 23:30pm on (b)(6) 2019 and completed at 04:30am on (b)(6) 2019.Investigation of this complaint found that the instrument operated within specification between 14 and 15 november 2019.On 18 november 2019, a leica global support application specialist provided the following feedback in relation to the circumstances described in this complaint: "the protocol that is indicated as causing poor processing is the "factory 4hr xylene standard small bigs".This protocol is as per factory recommendations.According to the tissue size recommendations in the peloris quick tips, a 4hr protocol is appropriate for small, non-dense tissues up to 3mm thick.A bone marrow biopsy of 2mm diameter would be more appropriately processed using a 1hr or 2hr protocol." based on the information available, it was determined that the root cause of the sub-optimal tissue processing reported by the complainant was use of a protocol of inappropriate duration for the size of the tissue samples being processed.The leica peloris quick tips in the section entitled tissue size recommendations- xylene and xylene -free; and section 8.2.1 of the leica peloris/peloris ii user manual tabulates the recommended protocol duration for maximum tissue dimensions and different specimen types.Specifically, it is recommended that endoscopies and needle biopsies with a maximum tissue dimensions of 1.5mm diameter are processed using a 1 hour protocol; and all biopsies up to 3mm diameter with a maximum tissue dimensions of <3mm: gi biopsies, renal, prostatic, hepatic and breast cores, punch biopsies of skin, small colonic polyps are processed using a 2 hour protocol.In this instance, bone marrow core biopsies were processed using a protocol of approximately four (4) hours duration, which is recommended for small non dense tissues (kidney, liver, bowel etc), excisional and incisional skin biopsies, skin ellipses.

Event Description

Leica biosystems received a complaint of "over processed tissues" following completion of processing.The leica applications specialist further documented the following information reported by the complainant: "the 9 specimens were compromised after being run on that processor last thursday night into friday morning.Although there are no error messages to report, we feel this machine may be malfunctioning because shorter runs of smaller tissue biopsies result in suboptimal tissue processing.The tissue were identified as over processed and were crumbling".On 19 november 2019, a leica applications specialist - usa (fss) visited the laboratory in order to investigate the circumstances involved in this complaint and to provide applications support.The fss documented the following information reported by the complainant: "(b)(6), and pa assistant, mentioned, "we specifically deleted the factory 4 hour standard small bigs protocol due to the continued issues (since we purchased the instrument back in 2007) related to only this protocol on this instrument.All other protocols render no issues".Additionally, the customer stated: "the processing issue wasn't addressed until after staining the slides.We melted the block down, let tissue reinfiltrate in warm paraffin for a few hours, then soaked and cut the blocks".The customer and i discussed: the large amount of formalin salts (which i / fss completed an acid flush), multiple broken bottle caps (noted to be replaced by the customer in the near future), paraffin over the max line in stations 1-4, cleaning of retort seals, general maintenance, ensuring correct gradient, and large amount of fat in reagent solutions/bottles." the fss also documented that the tissue samples exhibiting sub-optimal processing were bone marrow core biopsy samples with a diameter of 2mm, which had been processed using the "factory 4hr xylene standard small bigs" protocol.On 19 november 2019, the leica applications specialist - usa received information that all cases involved in this event 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, 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: 9485581
• MDR Text Key: 220107598
• Report Number: 8020030-2019-00058
• 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: 12/18/2019

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
• Device Catalogue Number: 26.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2007
• 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