Indications and Safety Information
Class I Recall: LifeSPARC™ Controller
On July 21, 2022, LivaNova reported a correction to its customers relating to the LifeSPARC controller, and per its 806 report, notified the FDA on August 4, 2022. The correction relates to modifications made to the Operations Manual to address situations during which certain users were unintentionally stopping the pump as a result of what is called a Critical Failure. In response, FDA classified this as a Class I recall. The Company takes this very seriously as patient safety is our top priority.
Brief Summary of Safety Information for TandemHeart® Transseptal Cannula Set
(Commercial, August 2020)
- 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.
- 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.
- 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.
- 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.
Brief Summary of Safety Information for TandemLife® LifeSPARC® System
(Commercial, August 2020)
- INDICATIONS FOR USE/INTENDED USE
INDICATION — The LifeSPARC pump is intended to pump 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.
INTENDED USE — The Pump is intended for use only with the LifeSPARC Controller.
- 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.
- 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.
The LifeSPARC System has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than six hours) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO).
The LifeSPARC System is for use with Adults Only.
The use of this device for periods longer than six hours 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.
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 this manual.
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.
- 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.
- ADVERSE EVENTS
Potential side effects of all extracorporeal circulatory support devices include, but are not limited to, sepsis, hemolysis, and thromboembolism.
Brief Summary of Safety Information for TandemLife® TandemLung® System
(Commercial, August 2020)
- INDICATIONS FOR USE/INTENDED USE
The TandemLung Oxygenator (TLO) is intended to be used for adult patients for extracorporeal circulation during cardiopulmonary bypass in the field of open-heart surgery. Within the indicated flow rates blood is oxygenated and carbon dioxide is removed. The utilization period of this device is restricted to six hours.
- WARNINGS & PRECAUTIONS– GENERAL
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 advantages of extracorporeal circulation need to be weighed against the risks associated with systemic anticoagulation.
The TLO may only be used by persons trained in extracorporeal circulation procedures.
TandemLife recommends the use of an oxygen-air blender (gas blender) for gas control during extracorporeal circulation.
Liquids should never be introduced into the gas pathways.
Excessive gas flow may cause hyperoxia, hypocarbia, alkalosis and/or blood trauma.
- WARNINGS & PRECAUTIONS – USE WITH ANESTHETICS AND MEDICATION
If injectable anesthetics such as Propofol are used, they should not be administered immediately upstream of the oxygenator. Furthermore, only small bolus rates or volumes per unit of time should be used because large drug boluses may create fat deposits that impair the function of the oxygenator.
The oxygenator with fiber membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane.
When using the TLO, methylene blue must not be administered directly before or during perfusion.
Arterial connections must not be used to administer medication.
- ADVERSE EVENTS
Possible side effects include infections, hemolysis, and embolisms. Side effects associated with extracorporeal circulation in general may also occur (e.g., post- perfusion syndrome and organ damage).
Brief Summary of Safety Information for TandemLife® ProtekDuo® Cannula Set
(Commercial, August 2020)
- INDICATIONS FOR USE/INTENDED USE
ProtekDuo Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
- CONTRAINDICATIONS
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 ProtekDuo Veno-Venous Cannula. These devices are not intended for use except as indicated.
- 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 ProtekDuo Cannulae has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., longer than 30 days) as a bridge to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO).
The use of this device for periods longer than 30 days increases the risk of 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.
Only medical personnel proficient in venous cannulation techniques and extracorporeal life support should use this device. Product is to be used in a controlled clinical environment by trained medical personnel.
Follow standard percutaneous or surgical techniques to place the device. Standard medical practice for cannula insertion site care should be followed to reduce incidence of infection.
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.
- ADVERSE EVENTS
Potential adverse events that may be associated with venous cannulation include: injury to or perforation of the myocardial wall with or without cardiac tamponade; thrombus formation; particulate or air embolism; myocardial infarction; pulmonary embolism; cardiac arrhythmias such as atrial fibrillation, heart block, sinus bradycardia, and ventricular tachycardia or fibrillation; congestive heart failure or pulmonary edema; atrial/ventricular 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; respiratory arrest; renal failure; death; failure to traverse the vascular system.
Additional Indications for Use
TandemHeart Controller: The TandemHeart Escort Controller is intended to be used with the TandemHeart System. The TandemHeart System consists of the TandemHeart Blood Pump, a single use, disposable device; the TandemHeart Escort (T.H.E.) Controller, a reusable control system for the TandemHeart Blood Pump; and disposable accessory items used in conjunction with the TandemHeart System.
TandemHeart Pump: The TandemHeart pump is intended to pump the 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.
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 Voyager Vest 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.
COVID-19 Temporary Indications
To address the COVID-19 public health emergency, the U.S. Food and Drug Administration temporarily expanded the availability of devices used in extracorporeal membrane oxygenation therapy. Select LivaNova ACS and cardiopulmonary products are currently indicated for ECMO therapy beyond 6 hours.