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

Model Number	2C8571
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three (3) clearlink system continu-flo solution sets leaked, and fluid was coming from the stopper of the distal y-site.The issue occurred during patient infusion.The issue was further described as the device leaked at the tip of the y-site where you connect a syringe.For one of the cases, the set was in use for 30 min on a pump and used herceptin.For the remaining occasions the set was in use for approximately 5 minutes with saline and for 2 hours with leucovorin respectively.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d4: expiration date (update the null value to n/a), h4, h6 (update codes), h11.H4: the lot was manufactured between 02/24/2025 and 02/25/2025.H11: the actual devices were not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the leak.Pressure and clear passage under water testing, and priming were performed on the sample; the device was found to be within the product specifications.Additionally, a functional flow rate test was conducted by connecting the companion sample to the spectrum iq pump simulating the usage process.The flow rate of the device was found to be within specification and no defects were observed that could generate a leak.The reported condition was not verified on the companion sample.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22700679
• Report Number: 1416980-2025-04019
• Device Sequence Number: 15740688
• Product Code: FPA
• UDI-Device Identifier: 00085412046327
• UDI-Public: (01)00085412046327(10)R25B24055
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 2C8571
• Device Catalogue Number: 2C8571
• Device Lot Number: R25B24055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: HERCPETIN; LEUCOVORIN; SALINE; SYRINGE; UNSPECIFIED PUMP
• Patient Sex: Unknown