MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/CONTINU-FLO/DUO-VENT; Set, administration, intravascular

Model Number	2C8541
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a continu-flo solution set with duo-vent spike separated at an unspecified location during a levophed infusion.The issue was identified when the patient¿s blood pressure monitoring indicated a decrease in blood pressure.As a result, a new infusion setup was initiated.No additional information is available.
Additional Manufacturer Narrative
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.

• 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 - 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: 50094078
• Report Number: 1416980-2026-02511
• Device Sequence Number: 10479470
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107(17)280322(10)R26C21031
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 2C8541
• Device Catalogue Number: 2C8541
• Device Lot Number: R26C21031
• 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: 07/08/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2026
• 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: Levophed infusion
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown