B. Braun Medical Inc. is aware of the recent FDA notification regarding the cybersecurity vulnerability ICSMA-19-274-01, also known as URGENT/11.

B. Braun proactively analyzed the software stack of product lines that could potentially be affected by this vulnerability. None of the B. Braun products listed use the operating systems detailed in the FDA safety communication nor do they use the vulnerable source code stack named IPnet. Product lines include Outlook^® Infusion Pump family, Space™ Infusion pump family (Infusomat^® Space Infusion Pump, Perfusor^® Space Infusion Pump, Space Station, and Space Wireless Battery), DoseTrac^® Server, DoseLink™ Server, Space Online Suite Server, APEX^® Compounder and Pinnacle^® Compounder.

B. Braun ensures high security standards throughout the product life cycle by using globally accepted standard test and verification methods. It has established processes to monitor the latest vulnerabilities, threats, or risks and will proactively implement measures as required.

FDA Advisory:

https://www.fda.gov/medical-devices/safety-communications/urgent11-cybersecurity-vulnerabilities-widely-used-third-party-software-component-may-introduce

Further information can be found at the Department of Homeland Security (DHS):

https://www.us-cert.gov/ics/advisories/icsma-19-274-01