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

Model Number	2R8537
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique device identifier (udi) # is based on the di information as no lot number was provided by the reporter.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 had a backflow.The issue was described as follows: the secondary iv bag was positioned lower than the primary 1000 ml bag.The unspecified secondary set, connected to the upper y site of the primary set, was attached to an empty secondary bag of unknown volume that had previously contained fluids and chemotherapy.During the flushing process, the line visibly cleared of chemotherapy; however, chemotherapy backflowed into the drip chamber of the primary fluid bag.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: g1, h4, h6 (update codes), h11.H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph showed fluid backflowing from the secondary set into the primary intravenous bag.The reported condition was verified.The cause of the condition could not be determined.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: 24626283
• Report Number: 1416980-2026-00982
• Device Sequence Number: 8689202
• Product Code: FPA
• UDI-Device Identifier: 00085412565743
• UDI-Public: (01)00085412565743
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 2R8537
• Device Catalogue Number: 2R8537
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY DRUG.; PRIMARY BAG.; SECONDARY BAG.; UNSPECIFIED SECONDARY SET.
• Patient Sex: Unknown