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	09/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station es, the system had ransomware attack, all the stations were on critical override and resync devices procedure on going.\ however, there were no delays 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-mar-2024 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 system had ransomware attack, all the stations were on critical override and resync devices procedure on going.A technical support specialist (tss) dialed into the station, logged in as carefusion admin, opened sql server management studio and executed the required station query in accordance with knowledge article \"es 1.7.X + datasync 2.0\", verified all transactions had been queued locally and successfully processed at the server, completed a station database backup following knowledge article \"how to create a station database backup\", opened the medes application and confirmed the upload queue size was 0 within sync status, performed a full station sync in accordance with knowledge article \"proper data sync 2.0 procedure\" without dropping the station database, configured station auto login as carefusion application and rebooted the station, dialed into the med es application server, executed the required structured query language query to review the station synchronization status, confirmed the expired message flag value was 0 in accordance with knowledge article \"expired messages in es 1.7\" indicating the expired message condition had been cleared, sent an email to the customer advising that the requested activities had been completed and verified successfully to resolve the issue.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): 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: 51119565
• Report Number: 2016493-2026-72265
• Device Sequence Number: 13524432
• Product Code: BRY
• UDI-Device Identifier: 10885403533242
• UDI-Public: (01)10885403533242
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2026

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: 09/17/2026
• Initial Report FDA Received Date: 10/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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