BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-

FDA device recall Z-1639-2025 · posted 2025-04-18 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

Action taken

On 3/11/2025, correction notices were mailed and emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, and other customers asking them to take the following actions: 1) Best practice is to verify the total dose being removed is accurate against the provider's order, and if available utilize barcode medication administration as an additional check to ensure the correct dose is retrieved prior to administration. 2) Customers can inventory the CUBIE pocket via a cycle count or blind count to correct the inventory when discrepancies occur. Customers can refer to the BD Pyxis MedBank Cabinet User Guide - 10000414987 Ver. 01, Version v2.4 for instructions. Refer to chapter six (6), page 103. 3)Customers should ensure backup procedures (which may include but are not limited to keys, emergency medication supplies, alternate devices in proximity, etc) are in place and staff have all been properly educated on them. 4) Share this letter with any facilities within your network that you may have distributed affected devices to. 5) Post this Recall Letter on or near affected products as a reminder of the recall and the steps/instructions that are needed to be followed. 6) Complete and return the Response Form via email to bdrc44@bd.com Firm is in the process of contacting all customers to schedule an appropriate time for the software upgrade to MedBank software version 1.7. If you require further assistance contact the firm's Technical support: 1-866-930-9251 Phone Hours: 24 hours, 7 days a week Website: https://bdx.my.site.com/CC360/s/impactedproducts?rn=MMS-24-5163/MMS-25-5183/5184

Root cause

Software design

Status

Open, Classified

Product code

BRY

Quantity affected

7,357

Distribution

US Nationwide distribution including in the states of MO, MI, FL, PA, SC, OR, AZ, CO, ND, GA, NE, TX, IL, OH, VT, IN, TN, KY, IA, MT, NY, CA, UT, OK, SD, WA, AK, ME, NV, NM, NC, WV, LA, MN, ID, AL, VA

Date initiated

2025-03-11

Date posted

2025-04-18

Location

San Diego, CA