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

Model Number	500001004001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation¿ es, station was stuck on initializing device manager screen.User rebooted the station but unable to sign in.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, 06-jan-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 refrigerator connected to the medstation was functioning, but the temperature display was blank, causing the system to not initialize properly.A field service engineer verified all connections between the medstation and the helmer refrigerator and confirmed they were properly connected.A hard reboot was performed following the correct procedure, starting with the helmer refrigerator and then the medstation.After completing the reboot process, both the medstation and the refrigerator, including the temperature display, were restored to normal functionality and confirmed to be in good working condition.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD PYXIS¿ PRO MEDSTATION¿ ES
• 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 ; 8586172000
• MDR Report Key: 25299370
• Report Number: 2016493-2026-32128
• Device Sequence Number: 9315002
• Product Code: BRY
• UDI-Device Identifier: 10885403521300
• UDI-Public: (01)10885403521300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 500001004001
• Device Catalogue Number: 1155-00
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD PYXIS¿ ES REFRIGERATOR
• Patient Sex: Unknown