MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C8419
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Awareness during Anaesthesia (1707); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3/d10: the event occurred within the last two weeks from when the issue was reported.D4: unique device identifier (udi) # is based on the di information as no lot number was provided by the reporter.H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink system solution set had no flow during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, f10, and h.1 b5: upon additional information, the reporter stated the unspecified ¿sedation¿ back flowed into the bag and the patient started to ¿wake up.¿ the clinician used the other line to bolus the patient to keep them sedated.There was no secondary tubing, there was two primary lines, one set was set to gravity (¿free flow¿) with the bag and the other set was to the pump.No further intervention was needed with the patient.No further information was available at the time of this report.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; street 2; singapore 73777 8; SN 737778
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23659872
• Report Number: 9612057-2025-00135
• Device Sequence Number: 10123677
• Product Code: FPA
• UDI-Device Identifier: 00085412048956
• UDI-Public: (01)00085412048956
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2C8419
• Device Catalogue Number: 2C8419
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown