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

Model Number	ALT2403
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: 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 a clearlink/continu-flo set disconnected and leaked.During an unspecified surgical procedure (also reported as endoscopy and unspecified surgical procedures requiring sedation/general anesthesia), the patient woke during the surgery which required the medical team to administer ¿more anesthesia via iv.¿ upon further inspection, it was discovered that there was a leak at the iv connection: specifically, between the hand and the iv tubing.The solution had pooled on the floor.The ¿connection appeared to be undone¿ leading to propofol leakage.No blood loss occurred.The leak was identified during the procedure when the patient regained consciousness.The duration of propofol therapy was more than 20 minutes.No further information was available at the time of this report.

• 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: 22236733
• Report Number: 1416980-2025-03392
• Device Sequence Number: 8027023
• Product Code: FPA
• UDI-Device Identifier: 00197886004359
• UDI-Public: (01)00197886004359
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: ALT2403
• Device Catalogue Number: ALT2403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 06/17/2025
• 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: PROPOFOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown