Class 2 Device Recall BD Pyxis" MedBank" MedPass Software

• Date Initiated by Firm: August 18, 2023
• Date Posted: September 28, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2646-2023
• Recall Event ID: 92967
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: BD Pyxis MedBank MedPass Software, REF: 139088-01
• Code Information: UDI-DI: 10885403513817, Software versions prior to but not including v1.2.3.23
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• Manufacturer Reason for Recall: After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.
• FDA Determined Cause: Device Design
• Action: On 8/18/23, correction notices were mailed to directors of Biomedical Engineering/Risk Management/Nursing/Pharmacy and distributors. They were asked to take the following actions: 1) Remind users that affected devices do not replace the electronic (or paper) patient record, specifically the medication order, which will remain accurate and serves as the source of truth for medication administration. Nursing best practice is to confirm the 5 rights of medication orders prior to administration. Some inpatient psychiatric units also utilize barcode medication administration (BCMA) which may detect duplicate administrations. If a duplicate medication is inadvertently administered, ensure the patient is appropriately monitored and follow organizational process for reporting of a medication error. 2. Please ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3. Complete and return the response form. Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service The recall issue will be resolved in software v1.2, which will be provided to all customers approximately October 2023 via remote upgrade. On 8/26/24, correction-update notices were sent informing customers the field correction (software update to BD Pyxis MedBank MedPass software v1.2.1.17) was not effective. As a result, devices required an additional update to BD Pyxis MedBank MedPass software version v1.2.3.23.
• Quantity in Commerce: 37
• Distribution: US: FL, MI, KS
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.