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

Model Number	500001002500
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es refrigerator, a failure occurred.The customer reported that the fridge was not unlocking the storage bins, preventing access to medications.Troubleshooting steps were performed, including rebooting the refrigerator and recovering the storage space; however, the issue persisted the customer stated that this malfunction occurred while dispensing the medication and 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, 03-mar-2023 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 device's irac boards were faulty.A field service engineer (fse) replaced the irac boards associated with both rows and reassembled the unit.After the replacement, diagnostics were performed to verify functionality.Although an acceptance test could not be completed because the refrigerator diagnostic test was unavailable in the installed software version, fse successfully tested the opening and closing of the bins in rows 1 through 5.All bins operated correctly, and the user was able to load medication into the drawers without any issues.The refrigerator was restored to normal operation and verified to be functioning properly.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: 50852215
• Report Number: 2016493-2026-65056
• Device Sequence Number: 18648297
• Product Code: BRY
• UDI-Device Identifier: 10885403510434
• 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): 08/28/2026

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: 500001002500
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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