MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Communication or Transmission Problem (2896)

Patient Problem Death (1802)

Event Date 04/29/2019

Event Type  Death  

Manufacturer Narrative

The motor is not a single use device.The approximate age of the device is unknown.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019.It was reported that the patient was suffering from primary graft dysfunction after a heart transplantation.The patient had been on extracorporeal membrane oxygenation (ecmo) since (b)(6) 2019 and was switched on (b)(6) 2019 to centrimag as a left ventricular assist device (lvad) and a right ventricular assist device (rvad) bridge to decision.During the operation, lvad support was successfully performed using the first centrimag console 2nd generation.However, when rvad support occurred the second centrimag console 2nd generation alarmed with the code s3 and there was no liters per minute (lpm) indication on the screen.After following the ifu instructions, the backup console was used as the rvad console instead.The patient later expired on (b)(6) 2019.The death was determined to be not related to the device but to neurology, as there was an absence of brain activity.The device was reported to have been operating as expected.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via the downloaded log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and was evaluated.The console did not return with a battery and a new battery was installed.The console was powered on as intended and passed the self-test.A log file was downloaded from the returned console for review.A review of the downloaded log file showed that on (b)(6) 2019 at 17:36, a s3 alarm occurred following a tech flow sub fault ¿can bus send error¿.The reported event was unable to be reproduced during the investigation.Preventative maintenance was performed.The console was then connected to the returned motor (serial #: (b)(6), mfr # 2916596-2019-02422) and flow probe (serial #: (b)(6)).The system was turned on and run at 5000 rpm for 24 hours.The reported event was unable to be reproduced.Battery maintenance was performed successfully.A functional test and a safety test were performed per procedure.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8624642
• MDR Text Key: 145545810
• Report Number: 2916596-2019-02232
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 201-90401
• Device Lot Number: 5526843
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death