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

Model Number 102956

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred at the arabian house in (b)(6).The allegation against the centrimag console is reported within mfr report number 2916596-2019-03682.The serial number of the motor was requested but not available.The device has not been returned for analysis.Similar reports has been investigated and the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott will perform a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The investigation will be submitted as a follow-up once it is complete.

Event Description

It was reported that a centrimag console gave s3 alarms.There was no patient involvement with this event.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via the downloaded log file.The centrimag motor was not returned for analysis; however, the associated and returned the centrimag 2nd generation primary console (refer to mfr.Report number 2916596-2019-03682) was returned for analysis and was investigated.The log file was downloaded from the returned console for review.A review of the downloaded log file showed the console operating as intended and displaying flow correctly until (b)(6) 2018.The sub fault ¿sf_ifd_flow_data¿ activated and triggered the ¿system alert: s3¿ in (b)(6) 2018 as well as (b)(6) 2019.The log file showed that the console was in the test phase or that bios battery maintenance had been started when the fault occurred.No event revealed that the console was in use with a patient when the fault occurred.The root cause for the reported s3 alarm was not conclusively determined in the motor investigation; however, it was further investigated under the console investigation (refer to mfr.Report number 2916596-2019-03682) and was conclusively determined to be due to a defective flow board in the console.No further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 8969423
• MDR Text Key: 156738822
• Report Number: 2916596-2019-04347
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1