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FDA Clears ICU Medical's Plum Duo™ Infusion Pump and LifeShield™ Infusion Safety Software

Wednesday, August 30, 2023

In a groundbreaking stride, ICU Medical, recognized globally for its pioneering medical innovations, has announced a major accomplishment. The company has secured the coveted 510(k) regulatory clearance from the esteemed U.S. Food and Drug Administration (FDA) for the remarkable pairing of the Plum Duo infusion pump and the LifeShield infusion safety software. This powerful amalgamation, heralding the Plum Duo pump alongside the LifeShield software, is slated to be at the disposal of U.S. customers by the dawn of 2024.

Diving into the heart of the matter, the Plum Duo pump marks an ingenious augmentation to ICU Medical's diverse infusion device arsenal, drawing from the precision-oriented cassette technology that has garnered accolades through the lauded Plum 360™. A vibrant color touch screen takes center stage, adorned with a user interface that is a testament to intuitive design. Housing a dual-channel architecture, the pump's capabilities extend to the administration of up to four compatible IV medications in unison, effectively embracing adaptability and responsiveness in fast-evolving settings.

Contrastingly, the LifeShield infusion safety software unfurls as a unified cloud-based suite, unfurling a host of advanced tools tailored to the nuanced management of drug libraries. As an enabler of seamless access, streamlined processing, and swift dissemination of pivotal information across sprawling healthcare ecosystems, the software stands as a testament to the concerted efforts of clinicians

Emanating further allure are the distinctive attributes that converge to render this infusion delivery platform highly efficacious. A luminous 10-inch full-color display serves as a conduit to an intuitive interface that lays bare the elegance of touch screen programming. With acumen in distinguishing pivotal infusion parameters and alarms, this interface assumes the role of a trustworthy guide, both in close quarters and at a distance.

Among other star features, the PlumSet™ cassettes take center stage, adorned with ICU Medical Clave™ needle-free connectors renowned for their prowess in mitigating infection risks. An in-line air trap, a guardian of closed systems, successfully curbs the menace of air-in-line alarms.

A simplified trajectory characterizes the deployment of drug library and firmware updates, orchestrated seamlessly from a central vantage, thus ensuring the perpetually updated status of devices, a testament to operational uniformity. Poised as a harbinger of ICU Medical's vision, the expansive LifeShield enterprise ecosystem anticipates a future marked by superlative IV pumps.

The debut of the Plum Duo IV infusion pump, harmonizing with the LifeShield infusion safety software, stands as a resounding complement to ICU Medical's comprehensive lineup of existing infusion systems, a constellation encompassing the Plum 360 large volume pumps, Medfusion 4000 syringe pumps, CADD-Solis™ pain management pumps, and CADD-Solis VIP™ ambulatory pumps. This milestone not only underscores ICU Medical's unswerving dedication to innovation but also underscores its unflinching commitment to ushering in an era characterized by patient-centric healthcare solutions.



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