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

Model Number	2R8538
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: h4, h6 (update codes), h11.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B3/d10: the event occurred in march 2026.H11: should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink system non dehp solution set had no flow during patient infusion.The primary set was primed with normal saline (ns) and loaded onto an unspecified baxter pump, with ns used as the carrier fluid.Durvalumab was prepared and spiked with unspecified secondary tubing (short set) and connected at the luer lock (y site) of the primary set closest to the baxter pump.Upon initiation, the pump immediately alarmed for occlusion, and the drug did not infuse.Durvalumab requires a filter.The tubing was placed on three (3) different baxter pumps, and all three pumps generated the same occlusion alarm.The short set was removed from the primary line.The y site near the patient was flushed and demonstrated blood return.The patient had an implanted port.The tubing was disconnected from the port, which was flushed with a pre filled ns syringe without resistance and demonstrated good blood return.A second bag of durvalumab was prepared with short set tubing; however, upon reconnection, the pump again immediately alarmed for occlusion, and the drug did not infuse.A third bag of durvalumab with short set tubing was prepared, primed with a filter, and tested without issue prior to patient connection; however, the pump again alarmed for occlusion.The y site closest to the pump was tested; however, ns would not flush, and no infusion was possible through the y site.The entire primary ns bag and tubing were replaced.Durvalumab was then connected to the new tubing and infused successfully.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; parque industrial itabo; carretera sanchez km 18 1/2; haina 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25035118
• Report Number: 1416980-2026-01489
• Device Sequence Number: 9175822
• Product Code: FPA
• UDI-Device Identifier: 00085412676647
• UDI-Public: (01)00085412676647(10)DR25J02017(17)271003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: Other
• Device Model Number: 2R8538
• Device Catalogue Number: 2R8538
• Device Lot Number: DR25J02017
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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; DURVALUMAB; IMPLANTED PORT; NS SYRINGE; PRIMARY NS BAG; UNSPECIFIED SECONDARY SET
• Patient Sex: Unknown