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

Model Number	500400001500
Medical Device Problem Code	Application Program Problem (2880)
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 matrix drawer map did not display on the screen when the drawers were opened during a case.Users were unable to enter a waste amount on the device because the number keys were unresponsive.The customer reported that a malfunction took place when the user tried to dispense medication to the patient.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, 26-jun-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 error in "multiple storage device security controller - raising device secured event for device.A technical support specialist (tss) remotely connected to station and reviewed the medapp logs, identifying the error "multiple storage device security controller - raising device secured event for device with path." tss applied the knowledge article "unable to enter waste amount on pas es; number keys unresponsive" and performed the recommended corrective actions.The server package files were placed in the designated updates directory, and the station was rebooted to initiate package installation.After the installation completed, a second reboot was performed.Tss then logged in with administrative credentials, repaired the anesthesia application through programs & features, and verified that the database recovery mode was configured as simple rather than full.Following completion of these actions, the station was restored to normal operation.The system functioned as intended after the technical support specialist troubleshot 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: 50942722
• Report Number: 2016493-2026-67426
• Device Sequence Number: 13145149
• Product Code: BRY
• UDI-Device Identifier: 10885403533242
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 06/26/2023
• 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