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

Model Number	338
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported that a pyxis anesthesia system received a database error popup while a patient was on the table.This error caused a delay to patient care.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.Patient or user harm was not reported.This event is recorded on complaint number (b)(6).A field service technician evaluated the device; the cause of this malfunction was determined to be a corrupted software application.The issue was resolved by a field service technician who restored the database from an available backup located on the server.This process is documented in knowledge article (b)(4).After completing those steps, the field service technician verified that the customer was able to access medications without complications.
Event or Problem Description
Customer reported that a pyxis anesthesia system received a database error popup while a patient was on the table.This error caused a delay to patient care.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.Patient or user harm was not reported.
Additional Manufacturer Narrative
The following fields have been updated with additional/corrected information: a1 patient identifier d4 model #, catalog #, and udi # d5 operator of device e3 initial reporter occupation h6 investigation codes 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 23-feb-2020 to 22-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 issue was due to database failure resulting in a delay in patient care.A field service engineer cleared the database, and verified customers were able to access medications.The system functioned as intended after field service engineer troubleshot the device.
Event or Problem Description
It was reported that a bd pyxis anesthesia system received a database error popup while a patient was on the table.This error caused a delay to patient care.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS ANESTHESIA SYSTEM 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
• MDR Report Key: 13791607
• Report Number: 2016493-2022-99054
• Device Sequence Number: 1805172
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: Health Professional
• Device Model Number: 338
• Device Catalogue Number: 338KMAT
• 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: 02/23/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2013
• 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