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

Model Number	338
Medical Device Problem Code	Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a pyxis anesthesia 4000 system froze during a procedure, causing a 5-minute delay for a user trying to remove medication.The affected procedure was irrigation debridement tibia surgery and fentanyl the required medication.Customer stated that there was neither harm nor discomfort to patient and no medical intervention was required as they rebooted the station to remove medication.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Upon investigation of the actual device used in this incident it was determined that the station's database was corrupted and that a clean database installation was required.The database was cleaned and replaced successfully to resolve.The system functioned as intended.
Additional Manufacturer Narrative
Section d4: corrected model number, catalog number and primary unique device identifier number.
Additional Manufacturer Narrative
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 01-dec-2021 to 01-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 station's database was corrupted and that a clean database installation was required.The database was cleaned and replaced successfully to resolve.
Event or Problem Description
It was reported by the customer that a bd pyxis anesthesia 4000 system froze during a procedure, causing a 5-minute delay for a user trying to remove medication.The affected procedure was irrigation debridement tibia surgery and fentanyl the required medication.Customer stated that there was neither harm nor discomfort to patient and no medical intervention was required as they rebooted the station to remove medication.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: 18407512
• Report Number: 2016493-2023-01281
• Device Sequence Number: 2673688
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829(21)14746135
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2025

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: 338
• Device Catalogue Number: 338KMAT
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: Not provided; 12/01/2023
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 06/04/2024; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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