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

Model Number	500004500001
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
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, 24-nov-2020 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 issue was caused by failed rear drawer controller boards.A field service engineer identified drawers 16 and 17 on the auxiliary med bank tower as non-responsive and diagnosed failed rear drawer controller boards.Ordered and replaced the faulty drawer controllers, restored responsiveness, and worked with support to configure the drawers.Verified full functionality with customer.The system functioned as intended after the field service engineer repaired the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux, users were unable to pull medications from drawers 16 and 17.Both drawers were observed in a yellow state.Remote troubleshooting was performed, and the populate function confirmed drawers 16 and 17 remained in a yellow state.Restarting the application did not resolve the issue, and the drawers remained inoperable.The customer reported that a malfunction took place when the user tried to dispense medication to the patient.There were no delay or adverse events or injuries reported based on this event.

• 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 SD; 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: 25516350
• Report Number: 2016493-2026-37286
• Device Sequence Number: 9827301
• Product Code: BRY
• UDI-Device Identifier: 10885403512575
• UDI-Public: (01)10885403512575
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/21/2026

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: 169-11
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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
• Patient Sex: Unknown