MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ PRO MEDSTATION¿ MAIN; AUTOMATED DISPENSING CABINET

Model Number	500001004001
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation¿ main, user reported while checking the machine, it was found screen was too faint and unable to read words.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, 23-dec-2025 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 user reported the screen was too faint to read clearly.The user checked several connections and rebooted the station multiple times; however, the issue persisted.The field service engineer (fse) confirmed that the pyxis pro screen was dim and not displaying correct contrast.The pyxis pro logo was burned into the screen and was visible on every display.The hard drive was reseated, and the display hdmi connection was reconnected, but the issue continued.The pyxis pro screen was replaced to resolve the brightness issue and logo burn in.After the new screen was connected, the display functioned normally.The system functioned as intended after field service engineer repaired the device.

• Brand Name: BD PYXIS¿ PRO MEDSTATION¿ MAIN
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; 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 ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 25026140
• Report Number: 2016493-2026-24548
• Device Sequence Number: 10133850
• Product Code: BRY
• UDI-Device Identifier: 10885403521300
• UDI-Public: (01)10885403521300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 500001004001
• Device Catalogue Number: 1155-00
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2025
• 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