MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDBANK TOWER AUX; AUTOMATED DISPENSING CABINET

Model Number	500004500001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pyxis medbank es system drawers failed to open when users tried to access medication.The customer stated that there was a delay in dispensing medication.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Upon investigation of the actual device used in this incident, it was determined that the drawers were not open.A field service engineer discovered that the power supply to the wall was inactive.Upon the arrival of the facilities team, they reset the breaker, after which all drawers functioned properly.The system functioned as intended after the field service engineer troubleshooted the device.

• Brand Name: BD PYXIS¿ MEDBANK TOWER AUX
• 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 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 21280661
• Report Number: 2016493-2025-02798
• Device Sequence Number: 20810489
• Product Code: BRY
• UDI-Device Identifier: 10885403517174
• UDI-Public: (01)10885403517174
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/16/2026

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: 500004500001
• Device Catalogue Number: 1146-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 07/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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