CENTRIMAG™ ACUTE CIRCULATORY SUPPORT SYSTEM
CONFIDENCE IN A SNAP
STREAMLINED LOCK DESIGN FOR SEAMLESS OPERATION
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Abbott 6101 Stoneridge Dr ., Pleasanton , CA 94588 USA Tel : 1 925 847 8600 Cardiovascular . Abbott / CentriMag
Rx Only Brief Summary : Prior to using these devices , please review the Instructions for Use for a complete listing of indications , contraindications , warnings , precautions , potential adverse events and directions for use .
CentriMag™ Circulatory Support System Indications [ PMA Approval ; 30-day use ]: Temporary circulatory support for up to 30 days for one or both sides of the heart to treat post-cardiotomy patients who fail to wean from cardiopulmonary bypass , providing a bridge to decision when it is unclear whether the patient ’ s heart will recover or whether the patient will need alternative , longer-term therapy .
CentriMag™ Circulatory Support System Contraindications [ PMA Approval ; 30-day use ]: The CentriMag™ Circulatory Support System is contraindicated for use as a cardiotomy suction device . The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative .
CentriMag™ Circulatory Support System Adverse Events [ PMA Approval ; 30-day use ]: Adverse events that may be associated with mechanical circulatory support can include , but are not limited to , the following : bleeding on device support , hemolysis , infection , renal failure / dysfunction / complication , respiratory dysfunction , hepatic dysfunction , cardia arrhythmias ( atrial or ventricular ), thromboembolism ( venous and arterial non-CNS ), hypotension , hypertension , device malfunction or failure , psychiatric events , right heart failure , and death .
CentriMag™ RVAS Indications [ Humanitarian Exemption Device ( HDE ) Approval ; 30-day use ]: The CentriMag Circulatory Support System is intended to provide temporary circulatory support for up to 30 days for patients in cardiogenic shock due to acute right ventricular failure .
CentriMag™ RVAS Contraindications [ Humanitarian Exemption Device ( HDE ) Approval ; 30-day use ]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device . The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative .
Humanitarian Device Statement : Caution : Humanitarian Device . The CentriMag Circulatory Support System is authorized by Federal Law for temporary circulatory support for up to 30 days for patients in cardiogenic shock due to right ventricular failure . The effectiveness of this device for this use has not been demonstrated .
CentriMag™ Circulatory Support System Indications [ 510 ( k ) Clearance ; 6-hour use ]: The CentriMag Extracorporeal Blood Pumping System is a non-roller-type cardiopulmonary and circulatory bypass blood pump used to pump a patient ’ s blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either : i . Full or partial cardiopulmonary bypass ( i . e ., circuit includes an oxygenator ) during open surgical procedures on the heart or great vessels : or ii . Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava
CentriMag™ Circulatory Support System Contraindications [ 510 ( k ) Clearance ; 6-hour use ]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device . The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative .
CentriMag™ Blood Pump Indications [ ECMO , 510 ( k ) Clearance ; > 6-hour use ]: The CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System ( Motor , Monitor , Console , and Flow Probes ) is indicated for controlling blood flow as part of an extracorporeal membrane oxygenation ( ECMO ) circuit . ECMO is intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patients ’ blood for adult patients with acute respiratory failure and / or acute cardiopulmonary failure , where other available treatment options have failed , and continued clinical deterioration is expected or the risk of death is imminent .
CentriMag™ Blood Pump Contraindications [ ECMO , 510 ( k ) Clearance ; > 6-hour use ]: The CentriMag™ System is contraindicated for use as a cardiotomy suction device . The System is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative .
CentriMag™ Blood Pump Adverse Events [ ECMO , 510 ( k ) Clearance ; > 6-hour use ]: Potential adverse events associated with the use of extracorporeal membrane oxygenation include , but are not limited to the following : Death , Mechanical Failures / Dysfunction , Bleeding ( including Cardiac Tamponade ), Hemolysis ( including Hemoglobinuria , Anemia , Hyperbilirubinemia ), Neurologic Dysfunction ( including Stroke , Seizures ), Cardiac Dysfunction ( including Myocardial Infarction , Arrythmias , Right / Left Heart Failure ), Hypertension , Hypotension , Vascular ( including Air Embolism , Thromboembolism ( venous / arterial ), Limb Ischemia , Vascular Damage ) Pulmonary Dysfunction ( including Pulmonary Embolism , Respiratory Failure ), Renal Dysfunction , Cardiogenic Shock , Hypovolemia , Hypervolemia , Hepatic Dysfunction , Coagulation Disorders ( including Thrombocytopenia , DIC ), Infection ( including Wound Dehiscence ), Metabolic / Respiratory Acidosis , Psychiatric Disorder .
CentriMag™ Blood Pump Indications [ 510 ( k ) Clearance ; 6-hour use ]: The CentriMag Circulatory Support System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass ( up to six hours ). It is also indicated for use in extracorporeal support systems ( for periods up to six hours ) not requiring complete cardiopulmonary bypass ( e . g . valvuloplasty , circulatory support during mitral valve reoperation , surgery of the vena cava or aorta , liver transplants etc .).
CentriMag™ Blood Pump Contraindications [ 510 ( k ) Clearance ; 6-hour use ]: The CentriMag Circulatory Support System is contraindicated for use as a cardiotomy suction device . The system is also contraindicated for patients who are unable or unwilling to be treated with an appropriate anticoagulant such as Heparin or a comparable alternative .
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