Thoratec CentriMag RVAS Instructions For Use Manual Download Page 1 | Manualshive

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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

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Summary of Contents for CentriMag RVAS

Page 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 ...

Page 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...

Page 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 ...

Page 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 ...

Page 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...

Page 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...

Page 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 ...

Page 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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