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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP Back to Search Results
Catalog Number 102953
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Death (1802); Neurological Deficit/Dysfunction (1982)
Event Date 05/11/2016
Event Type  Death  
Manufacturer Narrative
The patient age was not provided. The patient weight was not provided. Approximate age of device: 8 days (calculated from date of implant to date removed). The centrimag blood pump was disposed of at the hospital as the customer reported that the device functioned without any issues, and therefore was not available for investigation. The instructions for use lists thromboembolic phenomena as a possible side effect that may be associated with the use of the centrimag blood pump. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient was ischemic post cardiotomy following a 3 vessel coronary artery bypass graft procedure with a mitral valve repair. At an unspecified time later, the patient "coded" and an impella percutaneous ventricular assist device was implanted. The patient was transferred from the outside hospital where the events occurred to an implanting center. Left ventricular centrimag and right ventricular tandemheart extracorporeal circulatory support devices were placed. The patient was reported to be adequately supported throughout the case; however, developed a change in neurological status. A ct scan of the head showed multiple infarcts, the origin of which was unclear. The pumps were all functioning normally and ran without any issues up until the time when support was withdrawn and the patient expired on (b)(6) 2016.
 
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Brand NameTHORATEC CENTRIMAG
Type of DeviceCENTRIMAG BLOOD PUMP
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
denise johnson
5050 nathan lane north
plymouth, MN 55442
651756-407
MDR Report Key5760740
MDR Text Key48499615
Report Number2916596-2016-01220
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2018
Device Catalogue Number102953
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/30/2016 Patient Sequence Number: 1
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