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

Model Number	500001004500
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator system had an issue where the refrigerator connected to the station was not opening, even after the customer rebooted the system.The customer reported that the door was failing to open and that the rear of the refrigerator was extremely hot.The customer also reported hearing a sizzling sound when the refrigerator door was opened earlier.The customer stated that there was a delay in patient care.There were no 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, 21-aug-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 actual device used in this incident, it was determined that the refrigerator connection failure.A technical support specialist (tss) received a report from the charge nurse that a sizzling sound was coming from the refrigerator.The tss explained that the sizzling sound was originating from the back of the evaporator plate.The refrigerator was also showing as unlocked even though it was physically locked and was displaying a failed status.The tss rebooted both the helmer refrigerator and the pyxis machine, which resolved the issue.The customer was shown how to power off the refrigerator using the backup battery and how to use the keys.All tests were completed successfully, and the refrigerator functioned properly, resolving the issue.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): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50837697
• Report Number: 2016493-2026-64711
• Device Sequence Number: 9949646
• Product Code: BRY
• UDI-Device Identifier: 10885403510434
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/31/2026

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: 137549-01
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown