MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - the (b)(4) primary console is not a single use device.The approximate age of the device will be submitted in the supplemental report when the manufacturer's investigation is completed.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that during animal trials in (b)(6) there was an issue with (b)(4) hardware.A console's screen went blank; the motor continued to run, however the user had to swap the console and motor onto a backup.The console and motor were both returned for evaluation.No additional information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a console's screen going blank was confirmed through the analysis of data log files associated with this complaint.These consoles were evaluated and tested by mcs zurich.The first log file was successfully retrieved from 2nd gen primary console l06383-0005 (reported under mfr#: 2916596-2019-00563).Per the log file, at approximately 5:23pm on jan 15, 2019 an ifd-shutdown (display dark) occurred.Subsequently, voltage errors occurred, followed by system alert:s3 and set pump speed not reached:m5 alerts being triggered on the console.During these events, speed dropped from ~4500rpm and a flow of ~4lpm to a speed of ~3400rpm and flow of 0lpm.Although the console displayed a flow of 0lpm, flow was still available.The reported event was confirmed.The second log file was successfully retrieved from 2nd gen primary console l06383-0006.Per the log file, at approximately 7:22am on january 22, 2019 an ifd-shutdown (display dark) occurred.Subsequently, voltage errors occurred, followed by system alert:s3 and set pump speed not reached:m5 alerts being triggered on the console.During these events, speed dropped from ~4700rpm and a flow of ~4.1lpm to a speed of ~3600rpm and flow of 0lpm.Although the console displayed a flow of 0lpm, flow was still available.The exact motor used with each respective console during the events captured in the log files could not be conclusively determined.The investigation of the returned centrimag 2nd gen primary console (serial number: (b)(6) was performed by the r&d department of mcs zurich.During their investigation it was found that the console operated as intended.No fault was found with the console.The console was tested together with its associated motor (serial number: (b)(6), reported under mfr#: 2916596-2019-04271).During testing, a motor-stop event was observed.However, this event could not be reproduced during further testing.Although the root cause of the event could not be reproduced, the returned motor remained suspect.The root cause of the events captured on jan 22, 2019 could not be conclusively determined.Corrective action (capa) was opened to handle the motor issue and root-cause investigation.The console was evaluated further by the service depot and no display issues were reproduced.However, the console's battery was due for its routine maintenance, which was performed successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.The serviced and tested unit was returned to the rental pool.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8324724
• MDR Text Key: 136618912
• Report Number: 2916596-2019-00651
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Device Lot Number: L06383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1