MAUDE Adverse Event Report: CAREFUSION 303, INC. CCE SITE (COVERED UNDER ENTERPRISE LIC.); AUTOMATED DISPENSING CABINET

Model Number	135343-01
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review of records dating january 2022-december 5, 2024, under capa 10308384.The late submission of this report is justified by 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.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 the date of manufacture, 06-nov-2013 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 cce service was stopped, and it was not able to login to deployment db.A technical support specialist restarted the cce service, and messages started crossing.The system functioned as intended after the technical support specialist troubleshot the device.
Event or Problem Description
It was reported by the customer that a cce site (covered under enterprise lic.) system was under critical override.There were no adverse events or injuries reported based on this incident.

• Brand Name: CCE SITE (COVERED UNDER ENTERPRISE LIC.)
• 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, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 23504358
• Report Number: 2016493-2025-131564
• Device Sequence Number: 9048558
• Product Code: BRY
• UDI-Device Identifier: 10885403928659
• UDI-Public: (01)10885403928659
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 10/29/2025

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: 135343-01
• Device Catalogue Number: 135343-01
• 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: 04/04/2023
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2013
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown