MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS ANESTHESIA STATION 4000; AUTOMATED DISPENSING CABINET

Model Number	338
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that a pyxis anesthesia system 4000 remained on windows update screen after device was rebooted during a procedure.Customer reported that the application did not launch upon reboot.Users were prevented from accessing the station.The nature of the procedure was not disclosed.Customer reported no actual harm to patient, only that patient experienced induced seizures lasting 200 seconds.This event is recorded on complaint number (b)(4).Technical support agent advised customer to reboot the device on a schedule.Issue resolved once device completed pending windows software updates.
Event or Problem Description
Customer reported that a pyxis anesthesia system 4000 remained on windows update screen after device was rebooted during a procedure.Customer reported that the application did not launch upon reboot.Users were prevented from accessing the station.The nature of the procedure was not disclosed.Customer reported no actual harm to patient, only that patient experienced induced seizures lasting 200 seconds.
Event or Problem Description
It was reported that users were unable to log into the machine and no users were found on the database of a bd pyxis anesthesia system 4000.The customer reported this station is almost never rebooted and was pending windows updates.The user was unable to access a required medication while a patient had induced seizures lasting about 200 seconds.The customer was unaware of requirement for scheduled reboots to allow for windows updates when not in use.The device rebooted during the procedure.The customer added that there was no actual harm to the patient and pharmacy is doing an internal incident.
Additional Manufacturer Narrative
This supplemental regulatory report is being submitted due to a retrospective review conducted through capa 10308384.The late submission of this supplemental report is due to the thorough and detailed nature of the retrospective review process.This process was essential to accurately capture all relevant data and ensure the integrity of our reporting.We have included the capa reference for the retrospective review in the additional manufacturer narrative section of the fda form 3500a, as recommended.The following fields have been updated with additional/corrected information: a1, b5, d1, d4, d5, g1, h6, h10, h11.A review of the complaint history for (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 (b)(6) was performed from 15-feb-2020 to 14- feb-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 windows update screen remained on after device was rebooted due to software malfunction.The technical support specialist deleted the cbs (log files) files that accumulated, verified that pagefile.Sys was moved to d drive and rebooted the system to resolve the issue.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD PYXIS ANESTHESIA STATION 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: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 13777545
• Report Number: 2016493-2022-99055
• Device Sequence Number: 1633191
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: Other
• Device Model Number: 338
• Device Catalogue Number: 338
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2017
• 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