MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation conclusion: the device returned for analysis.The complaint investigation determined the reported event was the result of a software design related issue.After review of this event and similar incidents, (b)(6) has decided to initiate a voluntary field action for centrimag.(b)(6) performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.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 (b)(4).The first log file was successfully retrieved from 2nd gen primary console (b)(4).Per the log file, at approximately 5:23pm on (b)(6) 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 (b)(4).Per the log file, at approximately 7:22am on (b)(6) 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)(4)) and motor (serial number (b)(4)) was performed by the r&d department of mcs (b)(4).During their investigation, it was found that the console operated as intended.No fault was found with the console.The reported issue was reproduced when the console was tested together with its associated motor (serial number (b)(4)).Further investigation revealed that the motor was responsible for the event observed in the field.Corrective action (capa) was initiated to handle the motor issue and root-cause investigation.Final disposition of the motor will be determined by the capa.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.

Event Description

It was reported that during animal trials in (b)(6) there was an issue with centrimag 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.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8969539
• MDR Text Key: 161210994
• Report Number: 2916596-2019-04265
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1