BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Recall
- Recall Number
- Z-2262-2024
- Event Number
- 94718
- Firm
- CareFusion 303, Inc.
- FEI Number
- 2016493
- Product Code
- FRN
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 21, 2024
- Posted
- July 3, 2024
- Address
- 10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386
Description
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.
On August 22, 2024 a subsidiary of Becton, Dickinson and Company (BD) issued a second "Urgent Medical Device Correction" notification via FedEx and E-Mail to new consignees as well as consignees that previously received the 1st recall notification on June 3, 2024. BD asked consignees to take the following actions: 1. If the PCU is connected to the Server, no further actions are necessary, and PCU will function as intended. 2. If the PCU loses connection to the Server, the wireless network indicator icon on the PCU will be in an OFF state (not illuminated), and the PCU can continue to be used. See scenarios below for next steps. a. Non-interoperability customers: The pump programming workflow does not change. If the PCU does not have the expected Data Set, the clinical end user can utilize manual programming as described in the BD Alaris" System with Guardrails" Suite MX User Manual. In addition, a new Data Set can be uploaded to the PCU using a serial cable (per BD Alaris" System Maintenance User Manual v12.5 or BD Alaris" Guardrails" Editor User Manual). b. Interoperability customers: The clinical end user should follow established Interoperability downtime procedures and manually program the infusion as stated in the BD Alaris" System with Guardrails" Suite MX User Manual. Manual programming includes normal access to the BD Alaris Guardrails" dose error reduction software (DERS) and configurations. In addition, the clinical end user can manually document the infusion in the Electronic Medical Record (EMR). 3. Please promptly complete and return the enclosed Customer Response Form within 15 days to acknowledge receipt of this notification and that you understand the information provided in this letter.
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI.
168 software version