DEVICE: TandemHeart (00814112020050)

A platform upon which modular devices of a cardiopulmonary bypass system (e.g., the blood pumps) are mounted to form the complete system. It typically includes electronics and control panels (e.g., microprocessors to control pump speed), and the main connection to the source of line power. It serves as the basic workstation for the operator to monitor and control the system's functions.

A collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.

A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.