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

Model Number	2C8548
Medical Device Problem Codes	Failure to Prime (1492); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified amount of clearlink system vented continu-flo solution sets had air in the "prime chamber".This occurred while priming the set, prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, f10/h6: medical device problem codes, h6, h11.H11: the actual devices were not available; however, forty-two (42) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage testing along with priming were performed with no issues or defects noted.Functional flow testing was performed and the sets worked according to specifications.The reported condition was not verified on the companion samples.There is no potential for harm to a patient as this event would be observed before attaching the sets to a patient.The clinician can choose to replace the device or connect a syringe/administration set directly to the catheter.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; 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: 21447114
• Report Number: 1416980-2025-00795
• Device Sequence Number: 7196712
• Product Code: FPA
• UDI-Device Identifier: 00085412071114
• UDI-Public: (01)00085412071114(10)R24E14086(17)260515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• 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): 03/27/2025

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: Other
• Device Expiration Date: 05/15/2026
• Device Model Number: 2C8548
• Device Catalogue Number: 2C8548
• Device Lot Number: R24E14086
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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
• Patient Sex: Unknown