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

Model Number	500001002506
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es tower, the system became frozen on the blue screen, and the remote support service (rss) went offline.The customer rebooted the station, but issue persisted.The customer stated that this malfunction caused a delay while dispensing medications to the patient and the user managed to get medications from pharmacy.However, there were no adverse events or injuries reported based on this incident.
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, 29-apr-2026 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 station became frozen on the blue startup screen.A technical support specialist (tss) deployed a package to restart the remote support service (rss) service and rebooted the station, restoring remote connectivity.The station was reconfigured to automatically launch the carefusion (cfn) application, but an initialization device manager error was observed, and an onsite field service technician (fst) visit was scheduled.A field service engineer (fse) found the station powered off.The station was powered on successfully, booted normally, and allowed user login.Pharmacy technician performed inventory activities and confirmed operation, although intermittent slowness was noted.The tss done multiple reboots and application verification with no errors or issues were identified and the station returned to normal operation.The customer confirmed functionality, and the issue was resolved.The system functioned as intended after the technical support specialist and field service engineer investigated the device.

• Brand Name: BD Pyxis¿ MedStation¿ ES Tower
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50801690
• Report Number: 2016493-2026-64010
• Device Sequence Number: 21476715
• Product Code: BRY
• UDI-Device Identifier: 10885403512674
• UDI-Public: (01)10885403512674
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 500001002506
• Device Catalogue Number: 352
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2026
• 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