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

Model Number	500001005001
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
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, 01-may-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 incident, it was determined that there were failed bins, specifically the tower auxiliary and bin 4.3, which failed to recover.A field service engineer inspected the station and found that the drawers had been recovered.The engineer ran hardware test application (hta) and confirmed that the drawers were operational.The system functioned as intended after the issue was resolved.
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator tower auxiliary and bin was failed to recover.The customer stated there was a delay to the patient's workflow.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¿ pro refrigerator, tower auxiliary and bin was failed to recover.The customer stated there was a delay to the patient's workflow.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Additional information: section b describe event or problem, section d medical device brand name and medical device model, section h imdrf annex codes and manufacture narrative.Upon investigation of the actual device used in this incident, a field service engineer inspected the station and found that the drawers had been recovered.The engineer ran hardware test application (hta) and confirmed that the drawers were operational.The system functioned as intended after the field service engineer inspected the device.

• Brand Name: BD PYXIS¿ PRO 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: 23253521
• Report Number: 2016493-2025-120998
• Device Sequence Number: 13325501
• Product Code: BRY
• UDI-Device Identifier: 10885403521294
• UDI-Public: (01)10885403521294
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 04/22/2026

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: 500001005001
• Device Catalogue Number: 177-184
• 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: 09/13/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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