MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 201-30300

Device Problems Device Stops Intermittently (1599); Power Problem (3010)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for analysis. It has not yet been received. The event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is complete.

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. No additional information was provided.

Manufacturer Narrative

The report of a extracorporeal circulatory (centrimag) console shutdown event could not be confirmed during the investigation of the returned centrimag 2nd gen primary console. 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. A review of the device history records revealed no deviations from manufacturing or quality assurance specifications. No further information was provided. The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7510107
• MDR Text Key: 108092492
• Report Number: 2916596-2018-01737
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 201-30300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 05/14/2018 Patient Sequence Number: 1