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

Model Number	500004500000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower, system drawer was offline, and the system was in destock mode.Pharmacy reported a recurring issue where drawers intermittently appear offline, and inventory is being destocked from different drawers.However, there were no delay to patient care and adverse events or injuries reported based on this incident.
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, 09-aug-2023 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 drawer was offline, and the system was in destock mode.A field service engineer (fse) investigated the drawer offline condition and system destock issue.The fse powered down the unit, replaced the universal serial bus (usb) data cable, rebooted the system, and verified that it was operating correctly.The fse worked with the technical support center to confirm that no additional issues were present.Based on further recommendations, the fse powered down the cabinet again and replaced the power supply unit (psu).The fse then reassembled the cabinet, reconnected all cables, installed a new power cable and a new uninterruptible power supply (ups), and performed boot testing.The system functioned as intended after the 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: 50942741
• Report Number: 2016493-2026-67454
• Device Sequence Number: 21215998
• Product Code: BRY
• UDI-Device Identifier: 10885403512568
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 169-24
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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