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

Model Number	500004500001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux matrix drawer 16 row board issue was encountered.The customer reported having a cubie removed from the drawer and was unsure of its correct storage location.However, there were no delays or 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, 14-jun-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 device cubie tray was damaged.A field service engineer (fse) investigated the customer report that a cubie would pop out and not remain secured in position when replacing an old cubie with a new one in the row tray.The customer did not have a spare cubie available for testing, and an inspection of the cubie tray revealed no visible damage to its components.Based on the symptoms, a replacement cubie tray was determined to be necessary.Upon returning to the site with the required part, fse serviced the station and identified the first-row cubie tray in fh drawer 16 as damaged.Fse removed the defective cubie tray and installed a new replacement tray.Following the repair, the customer successfully inventoried the drawer pockets and verified proper operation, with all results confirmed as satisfactory.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: 50853247
• Report Number: 2016493-2026-65201
• Device Sequence Number: 21338535
• Product Code: BRY
• UDI-Device Identifier: 10885403517174
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/09/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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