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

Model Number	500001002002
Medical Device Problem Codes	Break (1069); Contamination (1120); Loose or Intermittent Connection (1371); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main, oral suspension had spilled onto the cubie lock board, causing aux 1 drawer 4 pockets a1 and a3 to not be detected on the bus.However, there were no delay to patient care and adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
E.1 initial reporter facility- (b)(6).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 of this incident, it was determined that the full height drawer 4 a1 had spilled liquid on it.A field service engineer (fse) replacing the cubie tray.All cables were reseated and verified, and a faulty slide bumper in aux drawer 4 was replaced, resolving the issue and restoring normal operation.The system functioned as intended after field service engineer repaired the device.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN
• 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: 25214276
• Report Number: 2016493-2026-30090
• Device Sequence Number: 10750016
• Product Code: BRY
• UDI-Device Identifier: 10885403512636
• UDI-Public: (01)10885403512636
• 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): 04/24/2026

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: 500001002002
• Device Catalogue Number: 306
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/19/2026
• 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