—#199540

Product

BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

FDA product code: BRY — Cabinet, Table And Tray, Anesthesia
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: REF/UDI-DI/Software: 323/10885403512667/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 352/10885403512674/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 327/10885403477836/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 1116-00/10885403512605/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4; 107-255-01/1.7.0, 1.7.1, 1.7.2, 1.7.3, 1.7.4

Why it was recalled

Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

Root cause (FDA determination)

Software Design Change

Action the firm took

On 4/5/23, correction notices were distributed to Biomedical Engineering, Risk Management, Nursing, Pharmacy Directors who were informed of the following: 1) Remind users that automated dispensing cabinet devices are not a replacement for the medical record (e.g., medication orders, medication administration record (MAR), and patient allergy information) and are not to be relied on as the source of truth for medication administration. Consult the hospital medical record before removing any medication. 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 to BDRC24@bd.com Recalling Firm Actions: 1. For customers who have reported an upload processing failure, the support team can provide a copy of affected data that is unable to be moved to the ES Server data repository. 2. A software update is available. The recalling firm will contact you to schedule a time to install the software update. For further assistance contact Customer Support at 1-866-583-8783, 5:00am PST to 4:00pm PST, Monday - Friday; or Technical Support, bd.com/self-service, 1-800-727-6102, 24 hours, 7 days a week

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 KS, NY, NC, LA, MA, MI.

Timeline

Recall initiated: 2023-04-05
Posted by FDA: 2023-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199540. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.