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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis MedStation ES (Med ES Main)

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 Class 2 Device Recall BD Pyxis MedStation ES (Med ES Main)see related information
Date Initiated by FirmApril 05, 2023
Date PostedMay 11, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1579-2023
Recall Event ID 92061
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductBD 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
Code Information 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
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
888-876-7128
Manufacturer Reason
for Recall		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 Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.
FDA Determined
Cause 2		Software Design Change
ActionOn 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
Quantity in Commerce1,474
DistributionUS Nationwide distribution in the states of KS, NY, NC, LA, MA, MI.
Total Product Life CycleTPLC 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.
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