—#203285

Product

BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: REF: 1116-00, UDI-DI: 10885403512605. Software Versions: 1.7.3 and 1.7.4 (Limited commercial release)

Why it was recalled

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

Root cause (FDA determination)

Software change control

Action the firm took

On 9/6/23, correction notices were mailed to customers informing them to do the following: 1) Do not use the global edit feature until your software is updated. 2) If a global edit has already been performed, it is recommended to verify that the formulary device settings are accurate for the 4 configuration settings. Controlled substances that have been edited via the global edit feature should be reviewed retrospectively for discrepancies in the destruction bin and a manual witness record may be needed until the settings are adjusted for both "Access Destruction Bin" and "Add to Destruction Bin (count/empty)." 3) Disseminate this notification within your facility network to ensure they are aware of this issue. 4) Complete the attached Customer Response Form and return via email to bdrc44@bd.com Software patch for v.1.7.3 was released on July 20, 2023, and commercial release software v.1.7.4 was released for on July 31, 2023. Firm will contact customers after the receipt of completed response forms to schedule times to install software update. The following contacts were provided: Technical Support, 1-800-727-6102, 24 hours, 7 days a week; Customer Self Service Portal, https://service.carefusion.com; North American Regional Complaint Center, 1-844-823-5433, Say "Recall" when prompted, Mon-Fri 8:00am and 5:00pm CT, email: productcomplaints@bd.com

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.

Timeline

Recall initiated: 2023-09-06
Posted by FDA: 2023-10-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203285. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.