Last updated: August 09, 2022
Original Publication: October 01, 2019
BD has assessed eight reported vulnerabilities that impact VxWorks, a real-time operating system (RTOS) from third-party vendor Wind River Systems, and three vulnerabilities that impact connected devices leveraging the Interpeak IPnet standalone TCP/IP networking stack associated with VxWorks. These vulnerabilities are not exclusive to BD, or medical devices that use VxWorks or the Interpeak IPnet standalone TCP/IP networking stack. BD is providing this update to educate customers on which BD products and under what conditions their devices could be affected by this third-party vulnerability
There have been no reported exploits of the BD Alaris™ PC Unit or any BD products associated with the vulnerabilities in this third-party software.
Remediation
BD has released the following Alaris™ PC Unit software, which addresses CVE-2019-12255 and CVE-2019-12264, also known as “Urgent 11:”
BD recommends that customers update to Alaris™ PC Unit versions 12.1.1 or newer, where available based on regulatory authorization. For assistance scheduling the remediation, customers should contact their BD Sales Representative.
BD determined it does not use any of the impacted versions of the VxWorks real-time operating system (RTOS). However, the following BD products do use the Interpeak IPnet standalone TCP/IP networking stack. IPnet is the wired/wireless network stack that the pump uses to communicate on the network to the BD Alaris Systems Manager Server:
Note: This list may be updated as necessary if new information becomes available. For those customers who do not use the wireless capabilities in the Alaris™ PC Unit, these vulnerabilities do not apply.
The Alaris™ PC Unit is potentially affected by two of the three reported vulnerabilities in the Interpeak IPnet standalone TCP/IP networking stack, specifically, CVE-2019-12255 and CVE-2019-12264.
A third vulnerability, CVE-2019-12262, does not affect the Alaris PC Unit, as BD specific configurations for the Alaris™ PC Unit does not use this functionality.
Note: These vulnerabilities have been assessed using the Common Vulnerability Scoring System (CVSS) version 3.0 ( https://www.first.org/cvss/) by Wind River Systems
The CVSS environmental score is specific to the customer’s environment and will impact the overall CVSS score. The environmental score should therefore be individually defined by the customer to accomplish final scoring.
CVE-2019-12255 has been assessed for clinical impact by BD. Based on the risk evaluation, the hazardous situations secondary to the keypad lock up (for example under infusion, delay in start of therapy or interruption of therapy when power cycling the pump to clear the alarm condition) could potentially result in patient harm, depending on criticality of patient and the type of therapy infusion at the time. The probability of harm is unlikely considering each individual device would need to be targeted via an exploit; there is a highly detectable alarm and the exploit would not interrupt the infusion. The medical benefits for continued use of the device outweigh the risks associated with these vulnerabilities.
CVE-2019-12264 has been assessed for clinical impact by BD and is a negligible risk. If successful, the Alaris™ PC Unit will be unable to communicate with the System Manager, however infusions will continue as intended.
For product or site-specific concerns, contact your BD service representative.