BD Pyxis MedBank MedPass Software, REF: 139088-01

FDA device recall Z-2646-2023 · posted 2023-09-28 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

BRY

Quantity affected

37

Distribution

US: FL, MI, KS

Date initiated

2023-08-18

Date posted

2023-09-28

Location

San Diego, CA