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

Model Number	PAS 4000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that a pyxis anesthesia 4000 system fingerprint reader, unexpected stopped responding during a scheduled hemicolectomy preventing user access to the station.Customer was able to retrieve the undisclosed required medication from a nearby station.The reported delay to patient care was 5 minutes.Patient or user harm was not reported.This event is recorded in complaint number (b)(4).A technical support specialist evaluated the device and observed that a nurse successfully logged into the station.The technical support specialist verified that there were no pending operating system updates as a precaution and rebooted the device.Device confirmed operational.
Event or Problem Description
Customer reported that a pyxis anesthesia 4000 system fingerprint reader, unexpected stopped responding during a scheduled hemicolectomy preventing user access to the station.Customer was able to retrieve the undisclosed required medication from a nearby station.The reported delay to patient care was 5 minutes.Patient or user harm was not reported.
Additional Manufacturer Narrative
The following fields have been updated with additional/ corrected information: a1, b5, d1, d4, d5, d9, e2, e3, g1, g6, h2, and 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 20-jul-2020 to 20-jul-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 fingerprint reader stopped responding.A technical service specialist noticed that nurses were attempting to login to the station.Performed soft reboot into station application and manually rebooting to resolve the issue.The system functioned as intended after troubleshot by the technical service specialist.
Event or Problem Description
It was reported by the customer that bd pyxis¿ anesthesia station es fingerprint reader stopped responding unexpectedly during a scheduled hemicolectomy, which prevented user access to the station.The customer was able to retrieve the required medication from a nearby station.There were no adverse events or injuries reported based on this incident.

• Brand Name: BD PYXIS¿ ANESTHESIA STATION ES
• 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 boulevard; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 15223857
• Report Number: 2016493-2022-99127
• Device Sequence Number: 5566525
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/28/2025

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: PAS 4000
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2013
• 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