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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
Model Number 102953
Device Problem Infusion or Flow Problem (2964)
Patient Problems Thrombus (2101); No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
The serial number of the device is not known. The device packaging and serial number information was disposed of. The approximate age of device: is not known. The device manufacturer date is not known. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was supported by an extracorporeal circulatory support device. The patient was removed from support, and the perfusionist reported a large blood clot in the blood pump around the rotor. There were no alarms and no patient issues associated with the thrombus. The thrombus was not discovered under support was discontinued. No additional information was provided.
 
Manufacturer Narrative
The pump was disposed of at the user facility and was therefore not available for evaluation. The report of a blood clot in the blood pump could not be confirmed nor correlated to a device related issue. It was reported that there were no alarms or patient issues. Thromboembolic phenomena are listed in the instructions for use as potential adverse events that may be associated with the use of the centrimag blood pump and warns the user to monitor the circuit carefully for any signs of occlusion. Additionally, the instructions for use explains that the pump is intended to be used with systemic anticoagulation and instructs the user to always have a spare centrimag blood pump, back-up console, and equipment available for change out. A review of the device history records revealed no deviations from manufacturing or quality assurance specifications. The manufacturer is closing the file on this event.
 
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Brand NameTHORATEC CENTRIMAG
Type of DeviceCENTRIMAG BLOOD PUMP
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich 8005
SZ 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 Key6553039
MDR Text Key74702091
Report Number2916596-2017-00925
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 06/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number102953
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 Received05/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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