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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

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THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR CARDIOPULMONARY BYPASS PUMP SPEED CONTROL Back to Search Results
Catalog Number 102956
Device Problems Overheating of Device (1437); Device Stops Intermittently (1599)
Patient Problem Thrombus (2101)
Event Date 12/13/2016
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the centrimag motor and primary console were returned for evaluation. The motor was allowed to run for an extended period of time without any issues being reproduced. The primary console was also tested for several days with the returned motor and no issues were identified. Both the motor and the console operated as intended with no issues found. A review of the device history records for both the centrimag primary console and the centrimag motor revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Manufacturer Narrative
Concomitant medical products: primary console: serial number (b)(4), manufacture date: july, 2013; ship date: 10/03/2013. The motor is not a single use device. Approximate age of the device is 8 years, 1 month calculated from the ship date of the motor (10/31/2008). The device is expected to be returned for evaluation. It has not yet been received. 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 membrane oxygenation (ecmo) on (b)(6) 2016. On (b)(6) 2016, it was reported that the patient developed a clot in the pump. This equipment had been placed on the patient on (b)(6) 2016. It was reported that the motor became hot to touch, and that no alarm was elicited from the console. The pump was exchanged; however, the motor would not operate the pump. After the console and motor were exchanged to the backup, the system functioned as expected. It was reported that on (b)(6) 2016, the patient expired, likely from a clotting disorder. It was reported that the patient's condition had started to deteriorate prior to the event. No additional information was provided.
 
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Brand NameTHORATEC CENTRIMAG MOTOR
Type of DeviceCARDIOPULMONARY BYPASS PUMP SPEED CONTROL
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zürich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
kathy reilly
6101 stoneridge dr.
pleasanton, CA 94588
9257380163
MDR Report Key6237630
MDR Text Key130368385
Report Number2916596-2017-00045
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number102956
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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