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

Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es server was down and ransomware attack caused all stations to enter critical override mode.However, there were no delays, adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
D.4 & h.4: serial number, unique device identifier, and manufacturer date not available.Upon investigation of the actual device used in this incident, it was determined that the facility experienced a ransomware/cybersecurity incident that caused the es servers and all pyxis devices to become unavailable, placing the stations into critical override mode and preventing communication with the server.A technical support specialist (tss) recovered the server and validated; it was confirmed that no database or snapshot restoration was required.All affected devices were then resynchronized in accordance with knowledge article (expired messages in es 1.7) to re-establish communication and download updated data.The resync process was completed successfully for the impacted stations, restored normal operation and server connectivity.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD Pyxis¿ ES Server
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50930746
• Report Number: 2016493-2026-67146
• Device Sequence Number: 18532670
• Product Code: BRY
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: S/N: (b)(6), Location:3A
• Patient Sex: Unknown