ICU Medical (Nasdaq:ICUI) announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software.
The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024.
Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on the cassette technology in the Plum 360 system. It features a large color touch screen with a highly intuitive user interface. With two channels, the system can deliver up to four compatible intravenous (IV) medications.
LifeShield infusion safety software, a unified, cloud-based suite, provides advanced new tools for comprehensive drug library management. ICU Medical says it fosters collaboration by enabling clinicians to access, process, and quickly share infusion information.
“Receiving FDA clearance for the Plum Duo pump and LifeShield software is the first step in realizing ICU Medical’s long-term vision of bringing customers best-of-breed devices with a shared platform and user experience,” said Dan Woolson, corporate VP and GM of ICU Medical Infusion Systems. “We are proud of this milestone and look forward to bringing our next-generation Medfusion and CADD products to the LifeShield platform, creating the most complete, precise, and technologically advanced infusion systems in the industry for our customers and their patients.”
More about the ICU Medical Plum Duo and LifeShield offerings
The company said it designed the new pump and software to help improve safety, accuracy, and efficiency in IV medication administration.
ICU Medical included the 10-inch full-color screen with guided touchscreen programming. It clarifies and differentiates important infusion parameters and alarms. The company says it provides easy-to-read near and far views of all parameters.
Its two-channel, four-line setup helps to enhance responsiveness in quickly changing environments, minimizing the footprint in high-acuity areas. ICU Medical also designed the system to feature a unique pumping mechanism to enable accurate and precise medication delivery.
The PlumSet cassettes feature industry-leading Clave needle-free connectors designed to reduce infection risks. ICU Medical’s system also includes interoperability and an in-line air trap to help maintain a closed system, reducing air-in-line alarms.
According to ICU Medical, its scalable cloud-based IV informatics solution can be deployed from a single facility to a healthcare system. It features centralized drug library management and reporting. LifeShield’s user interface, designed in collaboration with pharmacists and nurses, facilitates efficiency. It offers enhanced content entry, drug library management, and collaboration.
ICU Medical added a simplified drug library and firmware deployment managed from a central location, too. This ensures consistent device updates, with pumps remaining on the most current software version. LifeShield’s enterprise ecosystem can also support the company’s roadmap of future best-of-breed IV pumps.