Plum Duo™ Precision IV Pump

The Plum Duo™ Precision IV Pump is a large-volume infusion pump with two independent channels for delivering parenteral fluids, medications, and blood products intravenously, intra-arterially, or subcutaneously. It is intended for use by licensed healthcare professionals in hospital and outpatient settings for adult, pediatric, and neonatal patients.

The subject device improves flow rate delivery accuracy to ±3% (compared to ±5% in the predicate), implements a new motor mechanism for higher precision in rate entry at low ranges (0.01 mL/hr increments vs. 0.1 mL/hr), and adds optional features like the piggyback 'Infuse to Empty' automation and optional disablement of VTBI alarms. All other characteristics—two channels, volumetric piston operation, sensors, WiFi connectivity, physical dimensions, power, battery, and display—remain identical to the predicate.

AAMI TIR101 (flow rate and bolus accuracy testing), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 14971:2019+A11:2021 (risk management), IEC 62366-1 (usability engineering), and FDA guidance documents on software content, cybersecurity, and human factors in medical devices.

The improvements in flow rate accuracy and precision rate entry represent refinements to the same fundamental pump technology with no change to intended use, patient population, routes of administration, or basic operational design. The new optional features (Infuse to Empty, VTBI alarm disablement) are automations of existing workflows with no impact on safety or effectiveness. Enhanced air detection alarms represent a safety improvement. All testing—including verification, validation, reliability, software, human factors, and cybersecurity—confirmed the device meets its design requirements and the predicate's safety and performance standards.