MAUDE Adverse Event Report: CAREFUSION 303, INC. Alaris System; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Model Number	8300
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had leak down test failed.There was no patient involvement.
Additional Manufacturer Narrative
A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Investigation summary: field technician stated issue of failed leak down test was not confirmed.On 16-sep-26, etco2 was received unboxed and with paperwork.Passed asm leak down test.No faults found.Device to be returned for processing.Unit was opened and calibration required.Failure investigation report attached to sales force.This report lists imdrf annex a, c, d, and g codes that are reportable malfunctions observed on the device during servicing.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.

• Brand Name: Alaris System
• Common Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50714865
• Report Number: 2016493-2026-62076
• Device Sequence Number: 9779149
• Product Code: CCK
• UDI-Device Identifier: 10885403520761
• UDI-Public: (01)10885403520761
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K243855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 8300
• Device Catalogue Number: 8300 Alaris EtCO2 Module
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown