BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES

FDA device recall Z-1207-2023 · posted 2023-03-17 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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.

Action taken

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

Root cause

Software change control

Status

Open, Classified

Product code

BRY

Quantity affected

7914

Distribution

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

Date initiated

2023-02-14

Date posted

2023-03-17

Location

San Diego, CA