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

Model Number	500004500000
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower, a user was unable to dispense oxycodone ir 5 mg tablet.Upon investigation, it was determined that the medication had been destocked by the system, making it unavailable for removal from the station.The issue was related to the item's inventory status.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, 30-apr-2024 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 item was destocked by the system and all drawers had failed, leaving the station unresponsive.The field service engineer (fse) arrived on site and waited for access keys before performing further inspection.During troubleshooting, a loose universal serial bus port was identified on the main logic board, causing intermittent loss of communication with the drawers when the connection was disturbed.After obtaining access, the controller board was replaced, and medbank support was contacted to configure the new board.Following configuration, drawer functionality was verified using diagnostic software, and all drawers operated normally with testing completed successfully.The system functioned as intended after field service engineer repaired the device.

• Brand Name: BD Pyxis¿ MedBank 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: 50897367
• Report Number: 2016493-2026-66425
• Device Sequence Number: 10761922
• Product Code: BRY
• UDI-Device Identifier: 10885403517167
• UDI-Public: (01)10885403517167
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/11/2026

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: 500004500000
• Device Catalogue Number: 1145-00
• 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: 08/30/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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