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

Model Number	500001002001
Medical Device Problem Codes	Application Program Problem (2880); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2025
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 refrigerator for 3nee compartment was not accessible.The indicator light on the small box was not illuminated, and the compartment did not attempt to open electronically.The customer confirmed it could be opened manually using a key, however during attempted recovery of the failed storage, the compartment did not attempt to open at all.The customer reported that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator 3nee compartment was not accessible.The indicator light on the small box was not illuminated, and the compartment did not attempt to open electronically.The customer confirmed it could be opened manually using a key, however during attempted recovery of the failed storage, the compartment did not attempt to open at all.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
Additional information: section h imdrf annex codes d4 & h4: serial number, catalog, model, unique device identifier and manufacturer date not available.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, good faith attempts were made to get the additional information.No responses received from the field service engineer (fse) and the fse manager.Work order was cancelled by fse.

• Brand Name: BD PYXIS¿ ES REFRIGERATOR
• 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: 24143077
• Report Number: 2016493-2025-149242
• Device Sequence Number: 13100735
• Product Code: BRY
• UDI-Device Identifier: 10885403512643
• UDI-Public: (01)10885403512643
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 02/13/2026

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: 12/27/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2011
• 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)
• Patient Sex: Unknown