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

Model Number	2R8546
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: patient is pediatric (infant).E1: initial reporter address: (b)(6).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 continu-flo solution set leaked from the middle y-site connection (protected by a non-baxter cap).The issue occurred during patient infusion with total parenteral nutrition (tpn) and lipids.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: two (02) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the leak.Pressure and clear passage under water testing, priming, and usage testing on an in-lab spectrum pump were performed on the samples; no defects were observed.A simulated usage test was performed on the samples over 24 hours and water referee back pressure test were performed on all the clearlinks; a static leak was detected in sample #1 at the second y-site clearlink and sample #2 had a static leak noted at the third y-site clearlink.As per the autopsy of the clearlinks, a small deformation at the seal area of the component clearlink center post was identified.The reported condition was verified.The cause of the condition is related to the automated assembly of the clearlink components during manufacturing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: e4, h10, h11.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22172332
• Report Number: 1416980-2025-03278
• Device Sequence Number: 20780810
• Product Code: FPA
• UDI-Device Identifier: 00085412565699
• UDI-Public: (01)00085412565699
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2025

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: 2R8546
• Device Catalogue Number: 2R8546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 07/15/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/11/2025; 07/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CUROS CAP.; LIPID.; TPN.
• Patient Sex: Unknown