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CentriMag

®

 RVAS (Blood Pump) 

Instructions For Use (IFU) 

 

READ ENTIRE CONTENTS PRIOR TO USING THIS DEVICE 

 
 

CAUTION  

Humanitarian Device: The CentriMag RVAS is authorized by Federal law to provide 
temporary circulatory support for up to 30 days for patients in cardiogenic shock 
due to acute right ventricular failure. The effectiveness of this device for this use has 
not been demonstrated. 

Caution: Federal law restricts this device to sale by or on the order of a physician. 

 

Thoratec Clinical & Technical Support Phone number(s) 

United States 

Emergency HeartLine™ USA:  
Thoratec Corporation 
Main Switchboard: 

Tel:    +1-800-456-1477 
Tel:    +1-925-847-8600 
Fax:   +1-925-847-8574 

Outside United 
States 

Emergencies outside USA: 
Urgent/24-Hour Europe: 
Thoratec Switzerland 
Main Switchboard: 

 
Tel: 

+1-925-847-8600 

Tel: 

+44 (0) 7659 877901 

Tel: 

+41 (0) 44 275 7171 

Fax 

+41 (0) 44 275 7172 

 

 
 
 
 

 
 
 
 
 
 
Manufacturer: 
Thoratec Switzerland GmbH 
Technoparkstrasse 1 
CH-8005 Zürich 
Switzerland  
www.thoratec.com 

US Headquarters: 
Thoratec Corporation 
6035 Stoneridge Dr. 
Pleasanton, CA 94588 
USA 
www.thoratec.com

 

 
 

PL-0085, Rev. 09 

May 2015 

DCO No. 15-032

 

Содержание CentriMag RVAS

Страница 1: ...on the order of a physician Thoratec Clinical Technical Support Phone number s United States Emergency HeartLine USA Thoratec Corporation Main Switchboard Tel 1 800 456 1477 Tel 1 925 847 8600 Fax 1 925 847 8574 Outside United States Emergencies outside USA Urgent 24 Hour Europe Thoratec Switzerland Main Switchboard Tel 1 925 847 8600 Tel 44 0 7659 877901 Tel 41 0 44 275 7171 Fax 41 0 44 275 7172 ...

Страница 2: ...ature on other ventricular assist devices the risks usually associated with use of these devices and from a review of the data obtained from the CentriMag VAD worldwide experience potential medical risks associated with use of the CentriMag VAD include Death Stroke Bleeding Reoperation Hemolysis Infection all cause Renal failure or dysfunction Respiratory dysfunction Hepatic Dysfunction Cardiac ar...

Страница 3: ...ates of bleeding and limb ischemia in males and a potential trend toward higher rates of infection arrhythmias and neurologic dysfunction in females None of these potential trends were statistically significant The small sample size and variability of patient population as evidenced in baseline characteristics makes it difficult to draw any conclusions Risks associated with the CentriMag RVAS are ...

Страница 4: ...ed only with the CentriMag drive console There are no safety or performance data known to Thoratec which establishes compatibility of any other manufacturer s devices or components to the CentriMag RVAS 11 Potential risk to the patient should be evaluated prior to changing a CentriMag Blood Pump 12 Frequent patient and device monitoring is recommended 13 Do not use the CentriMag Blood Pump if the ...

Страница 5: ...roperly maintained CentriMag drive Console and Motor 12 Do not use the CentriMag Blood Pump if it has been dropped Dropping or other severe shock may cause damage which could lead to device malfunction 13 Do not use excessive force to install tubing on the CentriMag Blood Pump as damage to the Blood Pump and 3 8 pump ports may occur 14 Take care to prevent damage to CentriMag Blood Pump connectors...

Страница 6: ...NING Do not over tighten sutures when securing cannulae to tissues and vessels Over tightened sutures may result in obstruction and interruption of blood flow through the cannulae Suturing used to secure cannula must be made with sufficient tension to hold the cannula in place over the full range of patient activity Failure to effectively secure cannulae in place poses risk of decannulation bleedi...

Страница 7: ...d Pump the tubing and the connections if any anomalies are noted immediately stop the Blood Pump clamp the outlet tubing and correct the anomaly before unclamping and restarting CAUTION Placing a tubing clamp on the tubing near a tubing connection point can damage the connector resulting in thrombus formation at the area of the damage WARNING If leaks or other anomalies are found on the CentriMag ...

Страница 8: ...ons Note Actual obtainable flow is dependent on the difference between the preload and afterload of the Blood Pump pump pressure differential the resistance to flow through the extracorporeal circuit components Cannulae tubing etc and the patient hemodynamics intravascular pressures cardiac output and available volume BLOOD PUMP SPECIFICATIONS Blood contact materials Polycarbonate Pump priming vol...

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