MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ ES Server; Automated Dispensing Cabinet

Model Number	500001002501
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es server, all stations were not communicating and were operating in critical override mode.The customer reported that all stations displayed a disconnected mode icon along with a critical override error.The customer was also unable to access the bd enterprise server.The issue affected all stations across the facility, resulting in delays in medication dispensing.Troubleshooting was performed, and the hospital it team confirmed there were no network issues; however, the issue persisted.The customer stated that there was a delay in patient care.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 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, 04-mar-2022 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 all station were not communicating and was in critical override mode.A technical support specialist (tss) remotely accessed the application, database, and reporting servers to investigate a database connectivity issue.The tss found that the database services were not running and identified that the servers had been restarted.The tss restarted the required services, restored database connectivity, and monitored system communication until normal processing resumed.The tss then verified successful access to the application and hospital system viewer, identified a delayed data extraction, transformation, and loading process, and restored the associated service on the reporting server.After confirming that data processing resumed successfully and all alerts were cleared, the tss contacted the customer, verified that the issue was resolved, obtained approval for case closure, and proceeded with closing the case.The system functioned as intended after the technical support specialist troubleshot the issue.

• Brand Name: BD Pyxis¿ ES Server
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50752272
• Report Number: 2016493-2026-62737
• Device Sequence Number: 9333234
• Product Code: BRY
• UDI-Device Identifier: 10885403518348
• UDI-Public: (01)10885403518348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 500001002501
• Device Catalogue Number: 1115-00
• 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: 08/17/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown