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

Model Number	2C8519
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
It was reported a clearlink continu-flo solution set potentially caused a downstream occlusion alarm on the baxter pump during patient continuous iv infusion of esmolol and heparin.The healthcare professional checked the iv tubing, flushed the peripheral iv line, and ensured that no clamps or kinks were present.The pump was restarted after each assessment, but the alarm reoccurred within a few minutes.During this period, the patient became tachycardic.No issues were noted with the heparin infusion, which continued to run without interruption through the same iv line.Clinician decided to replace both esmolol infusion bag, tubing and pump.Once done, the patient's heart rate decreased by 40 beats per minute.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information was added to d9, h3, and h6.The device was received for evaluation.Functional testing was performed and did not identify any issues related to the customer reported condition.Pressure testing and a clear passage test under water were conducted.The sample was tested under water and the results were satisfactory, with no defects observed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24649186
• Report Number: 1416980-2026-01021
• Device Sequence Number: 18615645
• Product Code: FPA
• UDI-Device Identifier: 00085412048994
• UDI-Public: (01)00085412048994
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2026

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: Health Professional
• Device Model Number: 2C8519
• Device Catalogue Number: 2C8519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ESMOLOL; HEPARIN; SPECTRUM IQ PUMP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown