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

Model Number	2R8538
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Primary tubing set issue: downstream occlusion alarm immediately when the chemo was started.The y-site or male luer lock adapter valve was clogged or would not infuse through.Y-site where the short set attaches to.The patient did not require pre-meds because he took dexamethasone at home.Drug was docetaxel.Nurse changed out the whole primary set, connected the short set to the new primary tubing and the chemo was able to infuse.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 24829319
• Report Number: 24829319
• Device Sequence Number: 10447008
• Product Code: FPA
• UDI-Device Identifier: 00085412676647
• UDI-Public: (01)00085412676647
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/02/2026
• Report Date (Section F): 04/02/2026

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: 2R8538
• Device Catalogue Number: 2R8538
• Device Lot Number: (10)DR25122024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/02/2026