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

Model Number	2C8537
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of continu-flo solution sets had bubbles in the line.This was observed when the nurse went to use the devices.The nurses would prime the sets and get all the bubbles out in preparation for the patient, prior to use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4, h4, h6 (update codes), h11.D4: lot #: unused potential lots r26c13055, r25g21031 and r26b19093 were returned d4: expiration date and h4: device manufacture date: the expiration date of potential lot r26c13055 is 03/13/2028 and the lot was manufactured between 03/13/2026-03/14/2026.The expiration date of potential lot r25g21031 is 07/21/2027 and the device manufacture date of the lot is 07/22/2025.The expiration date of potential lot r26b19093 is 02/20/2028 and the device manufacture date of the lot is 02/20/2026.H11: the actual devices were not available; however, eight unused samples from three potential lots were received for evaluation.Visual inspection was performed on the samples and the components were correctly placed and according to specifications.Pressure test and clear passage test were performed and no defect was observed.The priming, the functionally test was performed and sets worked according to requirements.The reported condition was not verified on the returned samples.A batch review of returned lots were 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 ; 2242705355
• MDR Report Key: 25174711
• Report Number: 1416980-2026-01633
• Device Sequence Number: 10190473
• Product Code: FPA
• UDI-Device Identifier: 00085412048970
• UDI-Public: (01)00085412048970
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

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: 2C8537
• Device Catalogue Number: 2C8537
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/12/2026
• 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
• Patient Sex: Unknown