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

Model Number	2H8603
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified quantity of non-dehp extension sets disconnected from at least one (1) patient.The event was further described as "the filter has evacuated spontaneously".This occurred while the sets were being used with a non-baxter primary pump set and a non-baxter infusion pump.This event resulted in fluid/medications spilling onto the floor and air in the intravenous (iv) tubing.This occurred during patient infusion with propofol and/or hydromorphone.The medications were disconnected from the patient after the infusion was paused.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3/d10 date: the events occurred on an unspecified date after february 2025.D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier ((b)(4)).The devices were 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; 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: 22109793
• Report Number: 1416980-2025-03107
• Device Sequence Number: 12543221
• Product Code: FPA
• UDI-Device Identifier: 00085412046433
• UDI-Public: (01)00085412046433
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K952074
• 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
• Report Date (Section B): 05/29/2025

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: Other
• Device Model Number: 2H8603
• Device Catalogue Number: 2H8603
• Device Lot Number: ASKU
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/29/2025
• 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: FRESENIUS KABI INFUSION PUMP; FRESENIUS KABI PRIMARY PUMP SET; HYDROMORPHONE; PROPOFOL
• Patient Sex: Unknown