MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS ANESTHESIA SYSTEM (PAS) 4000; AUTOMATED DISPENSING CABINET

Model Number	327
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon investigation of the actual device used in this incident it was confirmed that the station randomly crashes when loading system services.The issue was resolved by replacing the station all in one unit and performing a database clone and transplant.The system functioned as intended.
Event or Problem Description
It was reported by the customer that a pyxis anesthesia es system unexpectedly rebooted/shut off in the middle of cases.No other information was released regarding the event.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Corrections and or additional information has been added to the following sections: a1, d1, d4, d5, d9, e3, h2, h6.A review of the complaint history for sn (b)(6) was performed in salesforce which did not locate similar complaints with the same failure mode for this serial number.A review of the device history record for sn (b)(6) was performed from 11-dec-2021 to 11-dec-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 system had performance issues.Field service engineer had reimaged the station as there were no available reimage ssd, replaced aio, cloned or2 ssd and reconfigured or4.The system functioned as intended after troubleshooted by the field service engineer.
Event or Problem Description
It was reported by the customer that a pyxis anesthesia es system unexpectedly rebooted/shut off in the middle of cases.No other information was released regarding the event.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS ANESTHESIA SYSTEM (PAS) 4000
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION 303; 10020 pacific mesa blvd.; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 10020 pacific mesa blvd.; san diego, CA 92130 ; 2105265020
• MDR Report Key: 18450493
• Report Number: 2016493-2024-00010
• Device Sequence Number: 7023968
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829(21)14947870
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 03/03/2025

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: Health Professional
• Device Model Number: 327
• Device Catalogue Number: 327KMAT
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2017
• 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