Indications and Safety Information

Brief Summary of Safety Information for the
LifeSPARC™ System

1. INDICATIONS FOR USE/INTENDED USE

INDICATION — The LifeSPARC System is a centrifugal blood pump system, intended to assist in circulation of the patient’s blood when part of an extracorporeal circuit including physiologic gas exchange of the patient’s blood, in adult patients with acute respiratory failure or acute cardiopulmonary failure, where other treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:
Ÿ  Failure to wean from cardiopulmonary bypass following cardiac arrest surgery in adult patients.
Ÿ  ECMO-assisted cardiopulmonary resuscitation in adults.

INTENDED USE — The Pump is intended for use only with the LifeSPARC Controller.

2. CONTRAINDICATIONS

Because of the non-occlusive nature of the Pump, the Pump should not be used for cardiotomy suction. The LifeSPARC Pump should not be used with extracorporeal circuits which create a pressure differential greater than 600 mmHg between the inflow and outflow of the Pump.

3. WARNINGS & PRECAUTIONS – GENERAL

Important: Physicians should inform patients about all potential risks and adverse events discussed in the Directions for Use and Operator’s Manuals. This document is not intended to serve as a substitute for the complete labeling.

Use of the LifeSPARC System beyond the duration established by the available in vitro, in vivo, and clinical data, has not been demonstrated. Refer to the full Directions for Use for a summary of bench, animal, and clinical studies performed, as well as for the possible clinical observations that may necessitate or predict the need for device replacement/change-out throughout the duration of use for this device.

The LifeSPARC System (Pump, Controller) has not been qualified for hemodynamic support for temporary ventricular support (duration of use ≤ 6 hours; 870.4360), or as a ventricular assist device (VAD – duration of use > 6 hours: 870.3545).

The use of the LifeSPARC Pump for periods longer than the duration established by the available in vitro, in vivo, and clinical data may result in pump failure, reduced pumping capability, excessive blood trauma, degradation and/or corrosion of the blood contacting materials (with the possibility of the particles passing through the CPB circuit to the patient), leaks, and increased potential for gaseous emboli entering the arterial line.

Continuous Renal Replacement Therapy (CRRT) is frequently used together with Extracorporeal Membrane Oxygenation (ECMO). CRRT use in ECMO may also correlate with severity of underlying disease. When used in extracorporeal circulation, the LifeSPARC Pump may correlate with increased incidence and frequency of CRRT use.

When used in extracorporeal circulation, the LifeSPARC Pump may elicit the need for exchange including, but not limited, acute thrombosis, ingestion of blood stream emboli, depriming due to air ingestion, or mechanical/electrical breakdown. The risk of circuit exchange may increase with duration of treatment, and clinicians should continuously monitor for signs of pump stress such as abnormal HQ performance, discontinuity between RPMs and Flow, unanticipated pump stoppage, and/or hemolysis and blood destruction.

When used in extracorporeal circulation, the LifeSPARC Pump may be subjected to differential load conditions and pharmacologic management strategies, in the context of various extracorporeal support modes. Clinicians should refer to the section on anticoagulation guidance, and anticipated pressure-flow relationships when managing patients with the LifeSPARC pump.

When used in extracorporeal circulation, the LifeSPARC Pump can induce negative pressures at the inflow limb, and care should be taken to avoid ingress of atmospheric gas via open ports in line, or communication between inflow cannula and other vascular access ports. Moreover, occlusion of the inflow limb with constant pump operation can also increase risk of cavitation, or gas embolism originating from vacuum applied to dissolves gases in the blood.

When used in extracorporeal circulation, the LifeSPARC Pump should be used along with surveillance of platelet count, fibrinogen levels, as well as signs and symptoms of thrombogenesis and coagulopathy, and consideration should be made to reduce RPMS to lowest necessary level to achieve goal blood flow.

Components of the extracorporeal circuit in series with the Pump will influence the attainable flow rates. In general, higher resistance upstream and downstream from the Pump will reduce the flow rate at given RPM settings of the Pump. Consult the pressure- flow curves in full Directions for Use.

The Pump should not be stopped for longer than five minutes without consideration of additional anticoagulation as the risk of thromboembolism is increased after blood has remained stagnant in the Pump.

During usage the Pump can get very warm. To prevent burn injury, make sure the Pump is secured in the Pump Holster.

Use in patients with II+ and higher aortic insufficiency may result in diminished net forward flow.

Support with the LifeSPARC System must only be initiated by operators with in- depth training in system use and extensive experience in the management of patients. The operator must have a thorough understanding of cardiac anatomy and physiology, hemodynamic monitoring, fluid and volume balance, and the management of inotropic and vasoactive drugs.

4. WARNINGS & PRECAUTIONS – ENVIRONMENTAL AND MEDICAL THERAPY HAZARDS INCLUDING MRI

The LifeSPARC System is MR Unsafe.

The LifeSPARC Pump bearing is stabilized by a series of strong magnets that create a strong magnetic field. Do not use LifeSPARC Pump in proximity of other devices that may have function altered in the presence of a magnetic field.

5. ADVERSE EVENTS

Potential side effects of all extracorporeal circulatory support devices include, but are not limited to, sepsis, hemolysis, and thromboembolism.

Intracranial hemorrhage is a known risk in adults treated with extracorporeal circulation, and risk is multifactorial. When used in extracorporeal circulation, the LifeSPARC may correlate with increased frequency of intracranial hemorrhage. When used in extracorporeal circulation, the LifeSPARC Pump should be used along with surveillance of platelet count, fibrinogen levels, as well as signs and symptoms of thrombogenesis and coagulopathy, and consideration should be made to reduce RPMS to lowest necessary level to achieve goal blood flow. Therapeutic anticoagulation should be achieved for insertion and maintained during patient support.

Brief Summary of Safety Information for the
TandemHeart™ Transseptal Cannula Set

1.  INDICATIONS FOR USE/INTENDED USE

The Transseptal Cannula Set is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

2.  CONTRAINDICATIONS

The Transseptal Cannula Set should not be used when any anatomical, medical, or physiological impairment may contraindicate the use of a femoral access procedure or transseptal access to the left atrium.

3. WARNINGS & PRECAUTIONS

Important: Physicians should inform patients about all potential risks and adverse events discussed in the Directions for Use. This document is not intended to serve as a substitute for the complete labeling.

The Transseptal Cannula is not intended to be extended into the left ventricle.

Product is to be used in a controlled clinical environment by trained medical personnel.

Medical personnel responsible for patient care should minimize the length of time that System components remain inserted or attached to the blood circuit during which there is no blood flow. Examples include start-up and shut-down procedures.

4. ADVERSE EVENTS

Potential adverse effects that may be associated with transseptal cannulation include the following: injury to or perforation of the myocardial wall with or without cardiac tamponade; thrombus formation; particulate or air embolism; myocardial infarction; cardiac arrhythmias such as atrial fibrillation, heart block, sinus bradycardia, and ventricular tachycardia or fibrillation; congestive heart failure or pulmonary edema; atrial septal defect, transient or persistent, with or without hemodynamic compromise; vascular injury with or without the need for surgical intervention; blood loss requiring fluid replacement or transfusion of blood products; infection; allergy or anaphylactic reaction to contrast media or device components.; loss of limb; respiratory arrest; renal failure; death; failure to traverse the vascular system.

Additional Indications for Use

ProtekSolo™ Venous Cannula: The Venous Cannula and Obturator is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The cannula obturator is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The introducer is only to be used with the appropriately sized Venous Cannula. These devices are not intended for use except as indicated above.

ProtekSolo™ 15 and 17 Fr Arterial Cannulae: The Femoral Arterial Cannula and Introducer are intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal support. These devices are to be used by a trained physician only.

Contraindications for Use: Alone, the cannula and introducer are not medical treatment devices. There are no known contraindications for the use of the cannula, other than those generally contraindicated for cardiopulmonary bypass. The cannula introducer is only to be used with the appropriately sized TandemHeart Cannula. These devices are not intended for use, except as indicated above.

VoyagerVest™: The VoyagerVest is intended to provide secure attachment of Extracorporeal Life Support (ECLS) components (pump, oxygenator, and tubing) to the patient during cardiopulmonary bypass.

Contraindications for Use: The VoyagerVest kit is only intended for use with compatible products manufactured and tested by CardiacAssist, Inc. The VoyagerVest kit should not be used on patients with a known allergy to neoprene.