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

Model Number PELORIS II

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation of this complaint found the instrument functioned as designed during execution of the protocols in which the fill time error code "130" had been recorded between 13 and (b)(6) 2015.The root cause of the "130" error code, which indicates a fill timeout error, was a blockage in the bottle 6 reagent line.The cause of the blockage in the bottle 6 reagent line could not be determined from the info provided.During attendance at the laboratory on 05/18/2015 to investigate the error code indicating a fill timeout error, the fse reported that the liquid level sensor (s) in both retorts a and b "have not been cleaned and are very built up and dirty".The fse demonstrated to the complainant how to clean liquid level sensors.The "daily maintenance reminder" page of the leica peloris quick tips details the following: "clean liquid level sensors (lls - 1, 3) and air hole".Section 7.2 of the leica peloris/ peloris ll user manual entitled "daily tasks" also details the following under the heading "clean retorts": carefully wipe the liquid level sensors.".

Event Description

Leica biosystems received a complaint regarding notification of fill timeout error code "130" for bottle 6 (ipa) during multiple processing runs involving both retort a and b.A leica field service engineer (fse) attended the laboratory on (b)(6) 2015 in order to investigate the circumstances involved in this complaint.The fse found that the liquid level sensor (s) in both retorts a and b "have not been cleaned and are very built up and dirty".The fse demonstrated to the complainant how to clean liquid level sensors; and reported that the "130" error code for bottle 6 reported by the complainant did not occur after the liquid level sensors had been cleaned.The fse performed several fill/drain cycles from bottles 6 and 7; inspected the bottle 6 fluid line; cleaned the rotary valve assembly and performed system verification testing, for which all results were satisfactory.The instrument was found to be operating within specification.On 05/26/2015, leica biosystems received info that the quality of tissue processing had not been impacted by the circumstances involved in this complaint.

• 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; melbourne, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn rd.; mount waverley; melbourne, victoria 3149 ; AS 3149 ; 92117535
• MDR Report Key: 4846757
• MDR Text Key: 22516436
• Report Number: 8020030-2015-00057
• 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: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2015
• 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
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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