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U.S. Department of Health and Human Services

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

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8936420
MDR Text Key155717648
Report Number2916596-2019-04115
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,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Lot NumberL04549
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2010
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: 08/27/2019 Patient Sequence Number: 1
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