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

Model Number	2C8537
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 udi: as the lot # is unknown, the udi will consist of the primary di number only.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.
Event or Problem Description
It was reported that a clearlink continu flo solution set leaked blood from a "pinpoint hole in tubing".The event occurred after the patient returned from an mri/ct procedure and was reconnected to monitoring in the cvicu.While the infusion pump was running levophed, the registered nurse (rn) observed blood backing up into the iv tubing, followed by a drop in the patient¿s blood pressure.The rn immediately began setting up a new pump and called for assistance.At that time, blood was observed dripping onto the floor from a pinpoint hole in the tubing.The rn stopped the infusion, disconnected the tubing, and obtained emergency levophed and new tubing to reprime the iv line.During this time, the patient¿s systolic blood pressure reportedly decreased to the 50 to 60 mmhg range.A medical doctor was present at the bedside, and a neosynephrine push dose was administered with minimal improvement.A new pump, tubing, and levophed infusion were initiated, after which the patient¿s blood pressure returned to baseline.No additional information is available.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25111504
• Report Number: 1416980-2026-01543
• Device Sequence Number: 9326428
• Product Code: FPA
• UDI-Device Identifier: 00085412048970
• UDI-Public: (01)00085412048970
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 2C8537
• Device Catalogue Number: 2C8537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• 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: INFUSION PUMP; LEVOPHED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown