MAUDE Adverse Event Report: CAREFUSION SD 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	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 8300 did not start the warmup and failed preventive maintenance during rate accuracy test giving an unknown error.There was no patient involvement.
Additional Manufacturer Narrative
Bd technical support troubleshoot with customer over the phone.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.Root cause: the probable cause of the reported device 8300 did not start the warmup and failed preventive maintenance during rate accuracy test giving an unknown error was not identified during the customer call.Recommended biomed to check if can do a basic run.Advise to download error log and view report.Following up with biomed but unresponsive.Biomed to call back if need further assistance.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

• Brand Name: ALARIS SYSTEM
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 23931650
• Report Number: 2016493-2025-146817
• Device Sequence Number: 5610081
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: (01)10885403830013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K031741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2025

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: Other
• Device Model Number: 8300
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• 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: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown