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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP

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THORATEC CORPORATION THORATEC CENTRIMAG CENTRIMAG BLOOD PUMP Back to Search Results
Model Number 102953
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 10/18/2017
Event Type  Injury  
Manufacturer Narrative
The right sided mechanical circulatory support device used at the time of the reported event was not returned for analysis. As a result, the report of hemolysis could not be confirmed during the investigation and the root cause could not be correlated to a device related issue. Hemolysis is listed in the centrimag instructions for use as a possible side effect that may be associated with the use of the centrimag blood pump. A review of the centrimag 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.
 
Manufacturer Narrative
The patient right heart failure and pulmonary clotting was reported under medwatch mfr report# 2916596-2017-xxxxx. The serial number was not provided. No additional information was provided. A supplemental report will be submitted when the device analysis is completed.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017. The patient struggled with oxygenation in the postoperative period. The patient was placed on extracorporeal membrane oxygenation (ecmo) with a centrimag pump and another manufacturer¿s oxygenator. The patient was eventually weaned from ecmo support, and supported on an rvad. Another manufacturer¿s percutaneous rvad was in place from the operative procedure, and was subsequently removed after ecmo support had been established. The patient was experiencing right heart failure as well as pulmonary clotting that resulted in oxygenation issues. Rvad speed was adjusted throughout the postoperative period due to low volume. It was reported that the patient experienced hemolysis that was possibly related to the rvad.
 
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Brand NameTHORATEC CENTRIMAG
Type of DeviceCENTRIMAG BLOOD PUMP
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7031317
MDR Text Key194234767
Report Number2916596-2017-02750
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 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2017
Is this an Adverse Event Report? Yes
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 Received02/13/2018
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

Patient Treatment Data
Date Received: 11/14/2017 Patient Sequence Number: 1
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