MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDSTATION¿ 4000; AUTOMATED DISPENSING CABINET

Model Number	500001002000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 station was stuck on the windows login screen.The customer stated that they tried to reboot the station, but the issue was not resolved.The customer stated that there was a delay in patient care.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, 08-nov-2018, 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 station was stuck on the windows login screen.A field service engineer upon arriving found that the station was rebooted and confirmed it powered on successfully.Later the customer confirmed that the station kept shutting down and the issue had recurred, ran diagnostics and found no issues with the power supply, however, observed liquid residue in the e-drawer area in front of and beneath the power supply, as well as on the upper rear section of the station, reviewed event viewer and confirmed no solid state drive (ssd) driver or related errors contributing to the shutdown, inspected all drawers and verified rear components were in good condition, noted legacy half-height drawer pockets required tapping to open, and recommended replacement if spares are available, proactively replaced the power supply, advised that all in one (aio) may have been exposed to liquid, but replacement was deferred per customer request, completed testing and confirmed the station was fully operational in diagnostics and application.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000
• 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: 25181103
• Report Number: 2016493-2026-29353
• Device Sequence Number: 18748828
• Product Code: BRY
• UDI-Device Identifier: 10885403512629
• UDI-Public: (01)10885403512629
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 500001002000
• Device Catalogue Number: 303
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2018
• 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