ICU Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Plum Solo precision IV pump, a single-channel device complementing the existing dual-channel Plum Duo.
The company also secured clearance for updated versions of the Plum Duo precision IV pump and the LifeShield infusion safety software, marking the full launch of the ICU Medical IV Performance Platform. The approvals will allow ICU Medical to introduce a new category of precision IV pumps and expand its platform offerings.
Precision IV pumps, unlike traditional models, are engineered to reduce delivery variability and support the demand for accurate data in patient care, said the company. The Plum Solo and Plum Duo, built on the cassette technology of the Plum 360, deliver a ±3% accuracy rate under real-world conditions, addressing inconsistencies found in traditional pumps. This technology provides clinicians with reliable infusion documentation and predictable performance.
ICU Medical Infusion Systems corporate vice president and general manager Chad Jansen said: “Precision IV pumps represent a critical step forward for infusion therapy.
“With the Plum Solo and Plum Duo, we’re introducing more than just a new device category – we’re setting a new standard. Healthcare teams can now trust not only the delivery of their medications but also the infusion data that supports their decisions, knowing it reflects what patients actually receive.”
The Plum Solo enhances the IV Performance Platform by offering a single-channel solution that works in tandem with the dual-channel Plum Duo. The Plum Duo has been highlighted in a KLAS Emerging Insights Report, receiving an A+ rating for new technology, recommendation likelihood, and value for money.
Together, the Plum Solo and Plum Duo offer healthcare systems the flexibility to select the appropriate configuration for their infusion requirements, optimising device footprint without compromising performance or safety.
Both devices maintain consistent ±3% accuracy and are compatible with whole blood and blood products, eliminating variability from external factors such as infusion setup and environmental conditions.
The IV Performance Platform provides several benefits, including precise delivery through a unique pumping mechanism, simplified user experience with intuitive touchscreens, streamlined medication management with centralised drug library and firmware updates, and full IV-EHR interoperability through LifeShield software.
The LifeShield enterprise ecosystem aims to deliver a unified IT platform for future infusion modalities.
