ICU Medical Inc. announces that it has received U.S. Food and Drug Administration (FDA) 510(k) regulatory clearance 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.

ICU Medical receives FDA clearance for Plum Duo infusion pump and LifeShield infusion safety software, part of the new ICU Medical IV performance platform.

The Plum Duo pump is the newest addition to ICU Medical’s portfolio of infusion devices and builds on the delivery of the cassette technology in the  Plum 360™. It features a color touch screen with a streamlined` user interface and two channels capable of delivering up to four compatible IV medications.

Moreover, LifeShield infusion safety software is a 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,” says 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 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.”

Key features of the Plum Duo infusion pump include:

  • Guided touch screen programming that differentiates infusion parameters and alarms to provide 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.
  • A pumping mechanism that allows for precise medication delivery.
  • PlumSet cassettes feature ICU Medical Clave needle-free connectors designed to help reduce infection risks.
  • An in-line air trap that helps maintain a closed system and reduce air-in-line alarms.
  • A scalable cloud-based IV informatics solution that can be deployed from a single facility to a healthcare system with centralized drug library management and reporting.
  • A LifeShield user interface designed in collaboration with pharmacists and nurses, which facilitates easy, efficient content entry, drug library management and collaboration.
  • Streamlined 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 future IV pumps.