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

Model Number	500001002001
Medical Device Problem Codes	Application Network Problem (2879); Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 console device was not listed and the unit was not communicating with the main unit.The customer reported that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
D4 & h4: serial number, catalog, model, unique device identifier and manufacturer date not available.Additional information: section h imdrf annex codes correction: section b describe event or problem, section d medical device brand name, medical device catalog, unique identifier (udi), medical device serial, medical device model, concomitant med prod data and section h device manufacture date upon investigation of this incident, a field service engineer (fse) confirmed that the issue was resolved by the customer by rebooting and recovering all the drawers, and no further investigation was required.The system functioned as intended after the customer resolved the issue.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main device was not listed and the unit was not communicating with the main unit.The customer reported that there was a delay in patient care.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 24494628
• Report Number: 2016493-2026-10670
• Device Sequence Number: 5017057
• Product Code: BRY
• UDI-Device Identifier: 10885403512643
• UDI-Public: (01)10885403512643
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 500001002001
• Device Catalogue Number: 309
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SN: (B)(6), LOCATION: PHARMACY.
• Patient Sex: Unknown