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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 patient¿s age and weight were not provided. The referenced 1st primary console that failed was reported under medwatch mfr report #2916596-2016-02193. 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
Additional information - multiple requests were made; however, the product was not returned for evaluation. The reported event could not be confirmed and a root cause could not be conclusively determined as the device was not returned for evaluation. The event could not be correlated to a device 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
ch-8005 zurich
SZ
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
kathy reilly
6101 stoneridge dr.
pleasanton, CA 94588
9257380163
MDR Report Key6092764
MDR Text Key59606612
Report Number2916596-2016-02194
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 05/04/2017
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 Received04/10/2017
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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