MAUDE Adverse Event Report: VISION BIOSYSTEMS LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number PELORIS

Device Problems Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

On 29 april 2015, leica biosystems received a complaint regarding failure of a cleaning protocol.A leica field service engineer (fse) attended the laboratory on (b)(6) 2015 in order to assess the operation and function of the instrument and to investigate the circumstances involved in this complaint.The fse reported that: ".The lls dirty, and pump diaphragm and retort seal all are out of tolerance, need to changed." investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Evaluation of the instrument logs showed that multiple event/error codes associated with liquid level sensor function had been recorded in the instrument logs; and that eight (8) cleaning protocols had failed in the period between 24 april 2015 and 29 april 2015.

Event Description

Investigation of this complaint by leica biosystems remains in progress.

Manufacturer Narrative

Manufacturer evaluation of the instrument logs confirmed that failure of the eight (8) cleaning protocols was associated with the lower liquid level sensor (lls) in both retort a and b not activating in the presence of liquid as expected; and showed that the lower lls in both retort a and b also did not activate as expected in the presence of liquid during tissue processing runs which completed prior to the leica field service engineer (fse) attending the laboratory on 30 april 2015.However, data in the instrument logs confirmed that the middle lls in both retort a and b functioned as expected, and each of the retorts filled with liquid as expected for all tissue processing runs in which the lower lls did not function as expected.As a consequence, tissue processing protocols were not affected by the functionality issues observed with the lower lls in both retort a and b.The fse cleaned the llss to remove residue during the site visit.The manufacturer findings are consistent with the fse on-site observation that the llss were "dirty"; and suggest that cleaning of the llss is not being performed in accordance with the manufacturer recommendations.The "daily maintenance reminder" page of the leica peloris quick tips details the following: "clean liquid level sensors (lls - 1, 2, 3) and air hole." section 7.2 of the leica peloris/peloris 11 user manual entitled "daily tasks" also details the following under the heading "clean retorts": "carefully wipe the liquid level sensors.".

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): VISION BIOSYSTEMS LTD.; 495 blackburn rd.; mount waverley; victoria 3149 ; AS 3149
• Manufacturer Contact: 6139211753
• MDR Report Key: 4810666
• MDR Text Key: 5917706
• Report Number: 8020030-2015-00049
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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