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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE Back to Search Results
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.
 
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Brand NameTHORATEC CENTRIMAG PRIMARY CONSOLE
Type of DeviceCENTRIMAG 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 Key7510107
MDR Text Key108092492
Report Number2916596-2018-01737
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
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 Received05/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number201-30300
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2018
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
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