—#197517

Product

BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: REF/UDI-DI: 327/10885403477836, 323/10885403512667, 352/10885403512674

Why it was recalled

Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

Root cause (FDA determination)

Software change control

Action the firm took

On 01/14/23, correction notices were mailed to directors of pharmacy informing them to take the following actions: 1) Ensure this letter and contents are forwarded and/or discussed with all appropriate personnel to ensure proper awareness of the issue. 2) If you are experiencing any issues, such as drawer failures, call BD technical support and refer to user guides for additional information and troubleshooting procedures. a. BD Pyxis MedStation ES user guide, refer to sections "Recover storage space" (Chapter 9, pg. 76) and "Emergency medication removal" (Appendix 11, pg. 119). See references 1 and 2 below for additional details. b. BD Pyxis PAS ES user guide, refer to sections "Emergency access procedures" (Appendix A, pg. 77) and "Storage spaces are not responsive" (Appendix B, pg. 81). See references 3 and 4 below for additional details. 3) Complete and return the Customer Response Form. The firm will take the following actions: 1) All customers who may have affected devices will be notified. 2) Upon receipt of completed response forms, the firm will coordinate the firmware upgrade with customers. Technical Support: 1-800-727-6102, Phone hours: 24 hours, 7 days a week

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: Worldwide - US Nationwide distribution including in the states of NY, PA, OH, TX, FL, KY, IL, DE, AK, WI, KS, LA, WA, AZ, CO, MI, IN, TN, SD, AR, MO, CA, NV, MA, SC, VA, WV, CT, ME, NE, RI, GA, NC, IA, MN, AL, OK, MS, NM, NH, VT, WY, OR, ID, NJ, UT, DC, HI, MD, MT, ND and the country of Canada.

Timeline

Recall initiated: 2023-02-14
Posted by FDA: 2023-03-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197517. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.