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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
Catalog Number 102953
Device Problems Infusion or Flow Problem (2964); No Flow (2991)
Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Thrombus (2101)
Event Date 10/04/2016
Event Type  Injury  
Manufacturer Narrative
The reported event of thrombus within the centrimag circuit could not be determined during the investigation as the pump was not returned for evaluation. The lot number of the centrimag blood pump was not provided; therefore, device history record review could not be completed. The centrimag blood pump instructions for use lists thromboembolic phenomena as possible side effects 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.
 
Manufacturer Narrative
The serial number of the device is not known. Due to the urgency of the operative case, the device packaging and serial number information was disposed of in the operating room. The approximate age of device: 12 days (calculated from date of implant to date removed. ) 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. It was reported that the patient was returned to the operating room (or) during the first postoperative night on (b)(6) 2016 for "clotted off lines. " it was reported that the bedside nurse clamped the outlet and inlet blood tubing due to visualized clot with "layering/separating of blood" in the blood tubing. Flow of 0. 0lpm was displayed on the device console. It was reported that the low flow alarm limit had not been set by hospital staff, and that the console was not alarming. The patient tolerated the disruption in support for a period of time; however, eventually became hemodynamically unstable. The patient was started on inotropic and vasoactive support due to mean arterial pressure between 20-30mmhg, and was returned to the operating room after exchanging the device and removing clot from the blood tubing, the patient stabilized. It was reported that there was not an issue with the extracorporeal circulatory support device or the primary console. The blood tubing had been caught under the patient's leg, and the tubing then clotted. The patient was brought back to the o. R. On (b)(6) 2016 to evacuate chest hematoma, and the patient was then weaned off of device support at that time.
 
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Brand NameTHORATEC CENTRIMAG
Type of DeviceCENTRIMAG BLOOD PUMP
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 94588
Manufacturer Contact
kathy reilly
6101 stoneridge dr.
pleasanton, CA 94588
9257380163
MDR Report Key6065009
MDR Text Key113310911
Report Number2916596-2016-02100
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 07/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received06/13/2017
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

Patient Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1
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