CENTRIMAG™ ACUTE CIRCULATORY SUPPORT SYSTEM
CONFIDENCE IN A SNAP
STREAMLINED LOCK DESIGN FOR SEAMLESS OPERATION
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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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