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The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous. The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use. The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The Cogent™ Hemodynamic Monitoring System (HMS) is intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. Suitability for use on a patient is up to the physician's judgment and the diameter to be used. The target population includes patients for whom hemodynamic monitoring will improve clinical care. The target populations are identical to those for the predicate devices and include: Critical Care Patients, Trauma Patients, Cardiac Surgery Patients. The Cogent™ HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters, and with ICU Medical Cogent™ sensors. The Cogent™ HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients. The intended environment for use is the hospital including Critical Care Units (such as Medical, Surgical, and Coronary), Trauma and Accident Emergency Units, Post Anesthesia Care Units, Operating Rooms, and Cardiac Catheterization labs. The Cogent™ HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and accident emergency units, coronary and intensive care units and cardiac catheterization laboratories. The CogentTM HMS is restricted to one patient at a time.

The Cogent™ HMS system is designed to compute and display cardiac and oximetry parameters relevant to patient care in the hospital acute care areas including Intensive Care Units and the Operating Room. Parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFloTM sensors. Input data for derived parameters may be keyed in by a clinician or may be obtained from a bedside monitor. The Cogent™ HMS provides the following functions: monitors patient cardiac output continuously, using continuous thermodilution, and intermittently, using bolus thermodilution; monitors cardiac output continuously using Pulse Power analysis on an arterial pressure waveform; monitors venous oxygen saturation by measuring the reflectance spectrum of the blood; and provides a general-purpose interface to the analog input/output channels of other monitoring devices. The Cogent" HMS consists of a base unit (patient interface module, PIM), a dedicated touch-screen display unit (user interface module, UIM) which allows for patient monitoring remotely (up to 50 feet), and the associated cables. The modules communicate with each other in docked, tethered (wired) or wireless mode. A physically separate optical module (OpMod) connects with an oximetry catheter. The Cogent™ HMS is designed for compatibility with PA catheters via connection to existing patient cables, i.e. unchanged cables as supplied with the primary predicate Q2 Plus. For the purpose of PulseCO™ data acquisition, the Cogent™ HMS is designed for compatibility with the CardioFloTM sensor and the new CardioFloTM reusable cable. In order to calculate blood oxygen saturation, the Cogent™ HMS is designed for compatibility with the existing optical module, its existing integrated cable and its associated compatible PA and oximetry catheters.