MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8486
Medical Device Problem Codes	Backflow (1064); Crack (1135)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a non-dehp solution set had an active bleeding at the patient¿s picc triple y site (precise source is unclear), as well as lipid and blood blackflow.The iv line reportedly cracked at the filter the preivous night, resulting in bleeding while the line was open; the ketamine pump was replaced at that time, and no further issues occurred when the filter was not in use.Line caps were changed at 04:00 during blood culture collection without prior concerns.The patient was later found "soaked in blood", prompting disposal of the tpn and initiation of new infusions.The picc itself appeared structurally intact, and no pump alarms occurred; the duration of time the patient was without analgesia is unknown.The following day, therapy was initiated using a spectrum iq infusion pump.A 1.2 micron filter was added to one limb of the triple y due to compatibility concerns between ketamine and amino acids.Immediately after filter placement, lipids were observed backflowing into the ketamine syringe line, and blood was backflowing from the red lumen; however, both lines flushed easily and remained patent.The spectrump pump was subsequently changed, after which flow normalized.It was noted "amino acids and lipids were taken down due to contamination concerns, and all lines were replaced".No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• 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: 24757875
• Report Number: 1416980-2026-01144
• Device Sequence Number: 8707681
• Product Code: FPA
• UDI-Device Identifier: 00085412565675
• UDI-Public: (01)00085412565675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2R8486
• Device Catalogue Number: 2R8486
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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: AMINO ACIDS; KETAMINE; LIPIDS; SPECTRUM PUMP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown