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

Model Number	2R8480
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot number: the customer reported lot # r25j221079; however, this lot number is not recognized by baxter.D4: unique identifier (udi) #: as the lot # provided is not recognized by baxter, the udi will consist of the di only.E1: initial reporter phone no.: (b)(6).The actual device was not available; however, a photograph and video of the sample were provided for evaluation.Visual inspection revealed that the gland of the y-site clearlink was leaking.The reported condition was verified.The cause of the condition was not determined.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink non-dehp solution set leaked from the y-site.This occurred during infusion of amino acids while the reporter was attempting to hang total parenteral nutrition (tpn).The reporter was having trouble getting the second filter primed, so they were using the pump to prime this last bit of tubing.When the reporter started the unspecified infusion pump, they noticed the amino acid solution was leaking out of the y-site where the lipids would be connected.The specific infusion rate was unknown, but was reported as ¿less than 75 ml/hr¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• 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 ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25641088
• Report Number: 1416980-2026-02157
• Device Sequence Number: 9423936
• Product Code: FPA
• UDI-Device Identifier: 00085412565750
• UDI-Public: (01)00085412565750(10)R25J21079(17)271021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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: Health Professional
• Device Model Number: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: R25J21079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 07/23/2026; 09/02/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/28/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2025
• 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: AMINO ACIDS
• Patient Sex: Unknown