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

Model Number PELORIS

Device Problems Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

Leica biosystems received a complaint regarding failure to drain the cleaning alcohol.Information reported by leica field service engineer (fse) suggests that a use error involving failure to complete the reagent replacement processing in accordance with the manufacturer instructions may have been involved in this event.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Manufacturer evaluation of the instrument logs did not identify any instance involving failure to drain the cleaning alcohol on (b)(6) 2016, as reported by the complainant.However, two (2) instances indicating insufficient reagent in bottle 6 (80/20 ethanol/ipa) and one (1) instance indicating insufficient wax in wax chamber 1 were recorded in the instrument logs on 14 december 2016.The instrument functioned as designed in each of these instances by substituting the bottle or wax chamber containing insufficient reagent with reagent or wax from a suitable alternative station.There are 687 instances in which an event code indicating insufficient reagent has been recorded in the instrument logs in the period between (b)(6) 2016; and there are 243 instances indicating that a bottle containing either a processing or cleaning reagent was not in contact with the corresponding sensor for less than 20 seconds, which is not sufficient time to complete manual replacement of the reagent; and the properties of the corresponding reagent station were reset in the period between (b)(6) 2016.Resetting a reagent station sets the concentration to the default value configured in the reagent types definition unless an alternative value is entered into the instrument software by the user; and resets the number of cassettes processed and the number of cycles and days to zero.The root cause of these events being recorded in the instrument logs are use errors involving failure to follow the manufacturer instructions related to both the fill level required for reagent bottles and wax chambers as detailed in section 2.2.2 of the leica peloris/peloris ll user manual and the manual reagent replacement procedure as detailed in section 5.4.4 of the leica peloris/peloris ll user manual.Although the complainant did not report any adverse impact on the quality of tissue processing, it is considered that the malfunction involving incorrect completion of the manual reagent replacement process would either cause or contribute to a serious injury upon recurrence because this use error has previously caused serious injury.

Event Description

There was no report of any adverse impact on the quality of tissue processing from the complainant in relation to this complaint.

• 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: 6248399
• MDR Text Key: 65079562
• Report Number: 8020030-2017-00005
• 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,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2009
• 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