Potential Adverse Events - Abiomed Impella RP Manual Del Usuario

POTENTIAL ADVERSE EVENTS

There are risks of complications with every procedure using a blood pump. These include
among others:
• Hemolysis
• Bleeding
• Immune reaction
• Embolism, thrombosis
• Vascular injury through to angionecrotomy
• Infection and septicemia
• Endocardiac injuries due to attachment by suction of the pump to the inferior vena cava
• Pump failure, loss of pump components following a defect
• Patient dependency on the pump after use for support
OVERVIEW
The Impella RP Catheter is an intracardiac microaxial blood pump that supports a patient's
®
pulmonary circulation. The Impella RP
vein and into the pulmonary artery.
When properly positioned, the Impella RP
in the inferior vena cava, through the cannula, to the outlet opening in the pulmonary artery.
Physicians and device operators monitor Impella RP
the Automated Impella Controller.
®
The intent of the therapy with the Impella RP
support system to restore normal right heart hemodynamics, reduce right ventricular work, and
allow the right heart time to potentially recover adequate contractile function or to be bridged to
the next therapy.
This section describes the components of the Impella RP
Controller, as well as the accessory components.
REUSABLE SYSTEM COMPONENTS
The Impella RP System consists of the following reusable components:
®
• Automated Impella Controller—provides the user interface, alarm indications, and
®
portable battery
• Automated Impella ® Controller cart—for easy transport of the Automated Impella
Controller
Impella RP ® with the Automated Impella
Catheter is inserted percutaneously through the femoral
®
Catheter delivers blood from the inlet area, which sits
®
® Catheter function on the display screen of
System is to provide a percutaneous circulatory
®
® Catheter and the Automated Impella
® Controller
®
®
5