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

Model Number	2C8851
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot #: the reported lot number r22105086 does not appear on the database.E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink system nitroglycerin set leaked from the tubing shaft close to the fluid chamber.This was observed when the second bottle of ivig (intravenous immunoglobulin) was initiated.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d4 (including expiration date update to n/a), d10 (add entry), h4, h6 (update codes), h11.Correction: a1, a2, a3a, a4-a6, b5, b6, b7, f10/h6: health effect - impact codes (replace code).A2, a3a, a4-a6: update to ni.B5: update "there was no patient involvement." to "there was no report of patient injury or medical intervention associated with this event." the leak triggered an air in line alarm on the pump.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage under water testing along with priming were performed on the sample; a leak was observed between the assembly of the tubing and drip chamber.Dimensional testing on the tubing was performed and the tubing met specifications.Additional visual inspection identified the insertion of the tube and solvent application were within specifications.The reported condition was verified.The cause of the condition could not be determined; however, potential cause may be due to a damaged drip chamber.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/DUO-VENT
• 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: 21778888
• Report Number: 1416980-2025-01909
• Device Sequence Number: 18301659
• Product Code: FPA
• UDI-Device Identifier: 00085412046365
• UDI-Public: (01)00085412046365(10)R22I05086
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150860
• 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): 05/09/2025

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: 2C8851
• Device Catalogue Number: 2C8851
• Device Lot Number: R22I05086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: IVIG; UNSPECIFIED PUMP
• Patient Sex: Unknown