MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	8300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual date of event is unknown.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: the returned device was fully evaluated, and no issues or anomalies were observed during the log review and laboratory testing.The external and internal inspections were performed on the suspect device and no obvious anomalies with electrical or mechanical components were found.The inside of the device was free of fluid ingress and corrosion.All inspected parts were manufactured by bd.A review of the pcu error logs, as well as the pcu battery log, showed no errors or malfunctions during the event date reported: 21 to 28 august 2025.The errors related to the etco2 module malfunction were first detected on august 29th, an error code 570.6500 (oem serious module error).The log analysis was performed based on the etco2 event logs from august 21 to august 28.The monitor is performing as intended, the monitoring always stops when the user presses channel off on the etco2.A functional test was performed on the devices in the ¿as received¿ condition.The suspect device was powered on, and during the boot sequence there were no irregularities observed.Neither the pca module nor the etco2 triggered any alarms during the testing process.A preventive maintenance was performed on the suspect etco2 module.The device passed all maintenance tasks.The bd alaris ¿ infusion system includes the pc unit (pcu) and one or more of the following: pump module, syringe module, end-tidal carbon dioxide (etco2) module, auto- id module, patient-controlled analgesia (pca) module, and associated software applications.Etco2 module is a capnograph that continuously monitors end-tidal carbon dioxide, fractional inspired carbon dioxide (fico2), and respiratory rate (rr).Bd alaris ¿ pump module and syringe module and alaris ¿ pca module are indicated for varying patient populations, routes of administration, and infusates.The system was being used for treatment purposes as intended per 21 cfr 820.198(d)(2).There was patient involvement but no harm.Root cause: the returned device was fully evaluated, and no issues or anomalies were observed during the log review and laboratory testing.Note that this report lists imdrf annex a0401, c07, d15, g02017 codes not associated with the reported event but identified as reportable malfunctions observed on the device during investigation are unrelated to the reported issue.These other failures presumptively did not cause or contribute to the reported issue.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.
Event or Problem Description
It was reported that the customer requested assistance in interpreting the logs for pca and etco2 modules.Specific time under review is from (b)(6) 2025 thru (b)(6) 2025.Customer states they are trying to understand when the etco2 module was activated and monitoring the patient versus not monitoring the patient.There was patient involvement, but no harm.

• 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: 24127315
• Report Number: 2016493-2026-01160
• Device Sequence Number: 18741945
• Product Code: CCK
• UDI-Device Identifier: 10885403830013
• UDI-Public: (01)10885403830013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K031741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/14/2026

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: Health Professional
• Device Model Number: 8300
• Device Catalogue Number: 8300 ALARIS ETCO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8015; 8120
• Patient Sex: Unknown