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

Model Number	500400001500
Medical Device Problem Codes	Circuit Failure (1089); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station es the device was not detected on bus.The customer stated that this malfunction caused a delay in dispensing medication to patients.However, 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, 13-dec-2022 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 was not detected on the bus.The field service engineer (fse) inspected the station and identified a failed controller board in drawer 5.Multiple attempts were made to restore communication by disconnecting and reconnecting the serial bus cable; however, the controller board remained undetected and was unavailable for testing in the hardware test application.An attempt to reassign the drawer was also unsuccessful.The failed controller board was replaced, and the drawer was reconfigured.Following the replacement, the drawer was successfully detected and tested.Comprehensive testing was completed using the hardware test application, and inventory verification was performed by the customer.The drawer functioned as intended, and all testing was completed successfully.The system functioned as intended after field service engineer repaired the device.

• Brand Name: BD Pyxis¿ Anesthesia Station ES
• 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: 50942540
• Report Number: 2016493-2026-67389
• Device Sequence Number: 21206972
• Product Code: BRY
• UDI-Device Identifier: 10885403533242
• 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): 09/07/2026

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: 500400001500
• Device Catalogue Number: 327
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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