MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ ANESTHESIA STATION ES; AUTOMATED DISPENSING CABINET

Model Number	500400001500
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaint history for sn (b)(6) was performed in salesforce which did not locate similar complaint(s) with the same failure mode for this serial number.A review of the device history record for sn (b)(6) was performed from the date of manufacture, 06-feb-2017 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.Upon investigation of this incident, it was determined that the patient records and associated orders failed to transfer.A technical support specialist (tss) accessed the station and executed the site down query, confirming that messages were current.There were no critical errors identified in health sight viewer (hsv).Upon reviewing a sample patient, it was found that the individual was admitted but the transfer message had failed to process.The customer was informed that all messages were current, and a re-send of the transfer message was requested.The sample patient was subsequently transferred to the unit under pre-admit status, resolving the issue.The system functioned as intended after the technical support specialist troubleshot the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station es had patient and orders not crossed over.The customer stated that this malfunction occurred while dispensing the medication and they had to access the medications from pharmacy that caused a delay in patient care.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ ANESTHESIA STATION ES
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 23541376
• Report Number: 2016493-2025-134733
• Device Sequence Number: 9609884
• Product Code: BRY
• UDI-Device Identifier: 10885403477836
• UDI-Public: (01)10885403477836
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 500400001500
• Device Catalogue Number: 327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown