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

Model Number	500004500001
Medical Device Problem Codes	Circuit Failure (1089); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux cabinet was rebooting unexpectedly at least five times per day.Followed these unexpected reboots, the cabinet did not consistently return to an online state automatically.In several instances, the customer was required to perform an additional manual reboot to restore functionality and bring the cabinet back online.However, there were no delays or adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
E.1.Initial reporter facility: (b)(6) hospital.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, 11-jul-2022 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 station displayed a black screen due to an intermittent connection issue.The field service engineer (fse) disconnected and reconnected the scanner usb cable.Coordinated with medbank support for remote diagnostics, which identified drawers 16 and 17 as non-functional.Shut down the device and replaced the controller cards for drawers 16 and 17, then rebooted the station.The system functioned as intended after the field service engineer repaired 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 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50911638
• Report Number: 2016493-2026-66559
• Device Sequence Number: 14801032
• Product Code: BRY
• UDI-Device Identifier: 10885403512575
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/08/2026

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: 169-128
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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