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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro refrigerator unable to access the bin.Customer stated that while recovering storage space, it would open but remain stuck on the message, "please pull open", even after they had pulled it open and closed it.The customer stated that this malfunction occurred while dispensing the medication which caused a delay to the 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, 05-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 actual device used in this incident, a field service engineer (fse) found that the customer had reported an issue with a bin in the pro refrigerator, where medications were showing in the bin even though it had been unloaded.Upon arrival, the issue could not be reproduced and appeared to have resolved itself.The fse performed a full inspection of all refrigerator bins and verified that they were correctly showing as active and in place.The pharmacy technician completed an inventory count to confirm functionality, and the fse tested the refrigerator using the hardware test application (hta).All tests passed, and normal operation was verified.The system functioned as intended after the field service engineer assessed the device.

• Brand Name: BD Pyxis¿ Pro 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: 50792517
• Report Number: 2016493-2026-63591
• Device Sequence Number: 18522813
• Product Code: BRY
• UDI-Device Identifier: 10885403521270
• UDI-Public: (01)10885403521270
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/22/2026

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: 177-138
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SN: (b)(6), LOCATION: PV12_C
• Patient Sex: Unknown