MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Communication or Transmission Problem (2896)

Patient Problems Stroke/CVA (1770); Death (1802); Thrombus (2101)

Event Date 12/31/2017

Event Type  Death  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-01737.This report is being submitted as additional information.The centrimag primary console is not a single use device.Investigation conclusion: the report of a centrimag console shutdown event could not be confirmed during the investigation of the returned centrimag 2nd gen primary console (serial number (b)(4)).A data log file was retrieved successfully from the console but the log started on (b)(6) 2018, after the reported event date of (b)(6) 2017.Since the console continued to be used after the reported event, older events in the log file were replaced by newer events.This is consistent with the report of the console being restarted and continuing patient support after the reported shutdown event.The returned console passed functional testing using laboratory test equipment and was able to support a mock circulatory loop without any issues, even when operated on battery power.Visual inspection of the external and internal connections did not reveal any issues or loose connections.The returned console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a console related issue.In order to perform further tests the monitor, motor, and flow-probe used at the time of the event would need to be returned for analysis.It is recommended that the customer not use these devices until they are returned for analysis.The labeling has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.(emergency/troubleshooting, doc # (b)(4)).No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was placed on extracorporeal circulatory support on (b)(6) 2017.It was reported that on (b)(6) 2017, the primary console shut down during patient transportation.The primary console was turned back on, and the device restarted and worked normally.The patient was conscious and recovered, but was weak.On (b)(6) 2018, thrombus was found in the circuit so the pump was exchanged.The patient had another stroke, lost consciousness and deteriorated after the pump exchange.Patient expired on (b)(6) 2018.No further information was provided.

Manufacturer Narrative

Correction to g1.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 8936420
• MDR Text Key: 155717648
• Report Number: 2916596-2019-04115
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: L04549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 47 YR
• Patient Weight: 37