Brief Summary of Safety Information for the
LifeSPARC™ System
1. INDICATIONS FOR USE/INTENDED USE
Extracorporeal Membrane Oxygenation: 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:
Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients.
ECMO-assisted cardiopulmonary resuscitation in adults.
Cardiopumlonary Bypass Support: The LifeSPARC system is intended to pump blood through an extracorporeal circuit for periods lasting less than six 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.
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.
