Plum Solo™ Precision IV Pump

The Plum Solo™ Precision IV Pump is a single-channel large-volume infusion pump designed to deliver parenteral fluids, medications, and blood products intravenously, intra-arterially, or subcutaneously. It is intended for use by licensed healthcare professionals in hospitals and outpatient facilities for adult, pediatric, and neonatal patients.

The subject device improves flow rate delivery accuracy to ±3% (compared to the predicate's ±5%), implements a new motor mechanism, and offers enhanced precision for programming concentration, flow rate, and VTBI entries. Key differences include a smaller 7-inch display (vs. 10.1-inch), reduced battery capacity (2500mAh vs. 3000mAh), addition of optional piggyback Infuse to Empty feature, and higher-resolution rate entry capabilities (0.01 mL/hr increments at low rates vs. 0.1 mL/hr). It is single-channel versus the predicate's dual-channel design.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), AAMI TIR101 (flow rate and bolus accuracy), ISO 14971:2019+A11:2021 (risk management), and IEC 62366-1 (usability engineering). Software validation followed FDA guidance from May 2005 and November 2021.

Although the Plum Solo has fewer channels (1 vs. 2) and a smaller display, it shares the same intended use, patient population, routes of administration, pump operation type, and compatibility with existing Plum administration sets and LifeShield software. The improvements in flow rate accuracy, rate programming precision, and optional workflow automation features enhance clinical capability without raising different safety or effectiveness questions. All differences are technological refinements rather than fundamental design changes, and comprehensive testing demonstrates the device meets applicable standards and predicate performance baselines.