BD Pyxis MedStation ES, REF: 323

FDA device recall Z-0670-2025 · posted 2024-12-11 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

Action taken

On 11/14/24, correction notices were mailed/emailed to customers: Devices can continue to be used in accordance with the following: Best practice is for providers (e.g., nurses) to verify the medication being removed is accurate against the hospital patient record (source of truth) prior to administration1. o Labeling includes the following warning: Always utilize the BD Pyxis ES System patient/order information in conjunction with the medical record when making clinical decisions. Making clinical decisions solely from System information may result in errors in care resulting in serious injury or death. " To further aid that verification step, it has been estimated that BCMA (Barcode Medication Administration) can reduce medication administration errors. Similarly, "Scan on Remove" functionality can be enabled within the MedStation to help capture an erroneously dispensed medication. " Safe storage and labeling for neuromuscular blocking (NMB) agents - Institute for Safe Medication Practices (ISMP) recommends to segregate, sequester, and differentiate NMBs from other medications. This can help identify a high-risk medication is being removed in error. " If a different medication is dispensed, the error may be caught during the check process prior to leaving the pharmacy. If error is not caught, pharmacy technician will still refill/load the medication dispensed properly at the device. " ES server includes notifications for those medication pockets that are empty within the System to trigger pharmacy to refill. Complete and return response form to BDRC1@bd.com For further assistance, contact firm: Technical Support - 1-800-727-6102, 24 hours, 7 days a week; Regional Complaint Center, 1-844-823-5433, Mon-Fri 8:00am-5:00pm CT, productcomplaints@bd.com; Post Market Quality Operations, Fax: 1-410-316-4258, Email: BDRC1@bd.com On 2/6/2025, updated correction notices were sent notifying customers that the firmware update was available.

Root cause

Software design

Status

Open, Classified

Product code

BRY

Quantity affected

98,526

Distribution

Worldwide - US Nationwide distribution including in the states of OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN

Date initiated

2024-11-14

Date posted

2024-12-11

Location

San Diego, CA