MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; Set, Administration, Intravascular

Model Number	2R8875
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a solution set with duo-vent spike exhibited no flow, resulting in under infusion of cyclosporine.The reporter stated that the infusion was attempted using three different baxter infusion pumps, and all three pumps generated downstream occlusion alarms when administration of the medication was attempted.The bedside nurse disconnected the tubing from the patient¿s central line and confirmed that the central line flushed without difficulty.The administration set was removed from the pump, all clamps were opened, and the cap was removed; however, no cyclosporine was observed dripping from the tubing.A syringe was used in an attempt to withdraw cyclosporine from the distal port of the tubing without success.The dose was reordered and the original dose was wasted, resulting in a delay of therapy of greater than two hours.The reporter stated that the patient did not receive the full prescribed dose.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4 udi: as the lot # is unknown, the udi will consist of the primary di number only.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): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago NA ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50855760
• Report Number: 1416980-2026-03002
• Device Sequence Number: 18515932
• Product Code: FPA
• UDI-Device Identifier: 00085412565637
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CA
• PMA/510(K) Number: K243529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 2R8875
• Device Catalogue Number: 2R8875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Baxter pump.; Cyclosporine infusion.
• Patient Sex: Unknown