MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ ANESTHESIA STATION 4000; AUTOMATED DISPENSING CABINET

Model Number	338
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a bd pyxis¿ anesthesia station 4000 had a station was not communicating.The customer stated that there was a delay in dispensing medication to a patient.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
A review of the complaint history for sn (b)(6) was performed in salesforce which did not locate similar complaints 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, 05-jun-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 the actual device used in this incident, it was determined that the acart was not communicating with the console, delaying surgery.A technical support specialist dialed into the console and the or2 station.The or2 station had been rebooted recently and had dhcp enabled, causing it to use a different ip address.The technical support specialist set the or2 station to utilize the new ip address in the console, dialed into the or2 station, and set the new ip address.After rebooting the or2 station, messages are now crossing over.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD PYXIS¿ ANESTHESIA STATION 4000
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 21921815
• Report Number: 2016493-2025-76721
• Device Sequence Number: 12947284
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/28/2025

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: 338
• Device Catalogue Number: 338
• 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: 04/03/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2017
• 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