MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ ES Refrigerator; Automated Dispensing Cabinet

Model Number	500001004500
Medical Device Problem Codes	Circuit Failure (1089); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator, the device became unresponsive after the refrigerator subsystem began continuously cycling through multiple screens.The user rebooted the entire medstation, during which system updates were applied; however, the station subsequently became stuck on the "initializing hardware" screen and was rendered unusable.There were no delay or 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, 02-sep-2021 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 frozen, and the refrigerator screen on the station was cycling through different screens.A field service engineer (fse) inspected the main station and refrigerator and found both devices stuck during startup.The fse determined that recent electrical issues had affected the refrigerator and prevented the main station from starting properly.The fse disconnected the refrigerator from the main station, reinstalled the required software components, and restored normal operation of the main station.The fse returned and replaced the refrigerator display, power board, control board, and other damaged circuit boards.The fse attempted to configure the refrigerator bins but encountered a configuration mismatch, requiring replacement of the interface boards.The fse returned with replacement interface boards, installed and configured the boards, and properly configured the secure refrigerator bins.The fse tested the refrigerator using the hardware test application and confirmed that the device was fully functional.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD Pyxis¿ ES Refrigerator
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50881885
• Report Number: 2016493-2026-66005
• Device Sequence Number: 10705277
• Product Code: BRY
• UDI-Device Identifier: 10885403510427
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 500001004500
• Device Catalogue Number: 137731-01
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD Pyxis MedStation ES
• Patient Sex: Unknown