ICU Medical Receives FDA Clearance for Plum Duo^™ Infusion Pump and LifeShield^™ Infusion Safety Software

San Clemente, Calif. August 29, 2023 – ICU Medical, Inc., a worldwide leader in the development, manufacture and sale of innovative medical devices, today announced that the company has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Duo infusion pump with LifeShield infusion safety software. The Plum Duo pump and LifeShield software will be available to customers in the U.S. in early 2024.

The Plum Duo pump is the newest addition to ICU Medical’s portfolio of infusion devices and builds on the precise delivery of the unique cassette technology in the Best in KLAS award-winning Plum 360^™. It features a large color touch screen with a highly intuitive user interface and two channels capable of delivering up to four compatible IV medications.

LifeShield infusion safety software is a unified cloud-based software suite that provides advanced new tools for comprehensive drug library management. It fosters collaboration by enhancing clinicians’ ability to access, process and quickly share information across an entire enterprise or health system.

"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 vice president and general manager of ICU Medical Infusion Systems. "We are proud of this milestone and look forward to bringing our next-generation Medfusion^TM and CADD^TM products to the LifeShield platform, creating the most complete, precise, and technologically advanced infusion systems in the industry for our customers and their patients."

As a large volume infusion delivery platform, the Plum Duo infusion pump with LifeShield infusion safety software are designed to help improve the safety, accuracy and efficiency of IV medication administration, with benefits including:

• A bright, 10-inch full-color screen with highly intuitive user interface with guided touch screen programming that clarifies and differentiates important infusion parameters and alarms to provide easy-to-read near and far views of all parameters.
• Two channels, with four lines to help enhance responsiveness in quickly changing environments and minimize the footprint in high acuity areas.
• Unique pumping mechanism allowing for accurate and precise medication delivery.
• PlumSet^™ cassettes featuring industry-leading ICU Medical Clave^™ needlefree connectors designed to help reduce infection risks.
• An in-line air trap that helps maintain a closed system and reduce air-in-line alarms.
• Interoperability built on ICU Medical's industry-leading 15-year history.
• A cloud-based IV informatics solution that is scalable and can be deployed from a single facility to a health care system with centralized drug library management and reporting.
• An engaging LifeShield user interface designed in collaboration with pharmacists and nurses, which facilitates easy, efficient content entry, drug library management and collaboration
• Simplified drug library and firmware deployment, managed from a central location to help ensure devices are consistently updated and pumps are on the most current software version.
• The LifeShield enterprise ecosystem that will support ICU Medical's road map of future best-of-breed IV pumps.

The introduction of the Plum Duo IV infusion pump with LifeShield infusion safety software is a complementary addition to ICU Medical's comprehensive portfolio of on-market infusion systems, which also features Plum 360 large volume pumps, Medfusion 4000 syringe pumps, CADD-Solis^™ pain management pumps, and CADD-Solis VIP^™ ambulatory pumps.