FDA Recall Open, Classified

Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

Recall: Z-1192-2023 · Initiated January 24, 2023

Recall

Recall Number
Z-1192-2023
Event Number
91582
Firm
CareFusion 303, Inc.
FEI Number
2016493
Product Code
FRN
Status
Open, Classified
Root Cause
Software Design Change
Initiated
January 24, 2023
Posted
March 1, 2023
Address
10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

Description

Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x.x.255

Reason

Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

Action

On 01/24/23, notices were mailed to customers, who were told to do the following: 1) Inspect the back of the PC Unit and observe the wireless card. Wireless cards that protrude out of the PC Unit are impacted. 2) Software version can be seen on the PCU using the following steps: a) Press Options Key, b) Press Page Down soft key, c) Press Software Versions soft key to display Software Versions menu, d) Press View soft key for the PCU. To prevent this issue from occurring, do one of the following: 1. Exclude IP address ranges ending in x.x.x.224 to x.x.x.255 from all the DHCP scopes where the affected PC Units are being utilized. 2. Assign the affected PC Units IP addresses utilizing DHCP reservations to prevent the PC Unit from obtaining an IP address in the aforementioned range. 3. Assign the affected PC Units a static IP address outside of the aforementioned range. Actions for Clinical Users: Check if wireless icon is illuminated. If the PC Unit is not connected to the wireless network when using Interoperability, the clinical user can input all infusion parameters manually. In addition, the clinical end user can manually document the infusion in the EMR. Data sets can also manually be programmed or uploaded to the PC unit using a serial cable. Continue to rely on hospital established protocols for wireless downtime procedures. Customers who require additional assistance can contact: Customer Order Management, 1-800-482-4822, [email protected]; Technical Support, 1-866-488-1408, [email protected]; Clinical & Pharmacy Support, 1-858-617-1316, [email protected]; BD Designated Complaint Handling Unit, 1-888-812-3266, [email protected] Complete and return the customer response form to [email protected]

Distribution

US: FL, CA, OR, IL, WI, NJ, AZ, NV, CO, WY, NE, TX, MI, VA, OH, NC, LA, NM, AL, TN, AR, PA, CT, IN, KS, GA, SC, MD, UT, MA, DC, OK, IA, NY, WA, SD, ND, MN, KY, MO, WV, MS, DE, ME, MT, ID, NH, HI, AK, VT OUS: Canada, Qatar, Saudi Arabia,, Kuwait, United Arab Emirates, Israel, South Africa, Zimbabwe, Botswana, Australia, New Zealand

Quantity

83,185