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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 102954
Device Problems Device Stops Intermittently (1599); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 10/14/2016
Event Type  Injury  
Manufacturer Narrative
The referenced back-up primary console that failed was reported under medwatch mfr report #2916596-2016-02194. The primary console is not a single use device. The serial number of the device was not provided, therefore the approximate age of the device, manufacture date and device unique identifier (udi) are unknown. The device is expected to be returned for analysis. It has not yet been received. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was placed on left ventricular extracorporeal circulatory support on (b)(6) 2016. It was reported that on (b)(6) 2016, the primary console "failed. " the pump speed and pump flow remained at 0 rpm and 0 lpm respectively. The patient was switched to the back-up primary console which also failed. Therapy was restored when the patient was switched to a third primary console. It was reported that the patient was symptomatic; however, the specific symptoms were not provided. It was reported that the user facility believed that the issue may be due to battery maintenance, which is being addressed by ensuring that battery maintenance is being done routinely and properly. No additional information was provided.
 
Manufacturer Narrative
The device was not available for evaluation. As a result, the reported event could not be confirmed and the root cause could not be conclusively determined. It was reported that the hospital's biomedical engineer performed a functional checkout and replaced the backup battery of the device. The device serial number was not provided; therefore, review of the device history records could not be performed. The manufacturer is closing the file on this event.
 
Event Description
Additional information: it was reported that the hospital's biomedical engineer performed testing of the device on a mock circulatory loop and completed a functional checkout. The backup battery was reportedly replaced during this procedure and the device would not be returned. Additional information was requested but not provided. The patient's symptoms were not specified and the serial number of the primary console was not provided.
 
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Brand NameTHORATEC CENTRIMAG PRIMARY CONSOLE
Type of DeviceCENTRIMAG PRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
ch-8005 zurich
SZ
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564071
MDR Report Key6092758
MDR Text Key59604012
Report Number2916596-2016-02193
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number102954
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 Received02/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/10/2016 Patient Sequence Number: 1
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