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

Catalog Number	2R8402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system non-dehp solution set leaked where the buretrol meets the iv tubing.This occurred during tpn (total parenteral nutrition) infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection was performed using the naked eye and there are areas with a potential no surface of contact between the tube and the drip chamber; the insertion depth of the tube into the drip chamber met specifications.Pressure and clear passage under water testing, and priming were performed which identified a leak between the assembly of the tubing and drip chamber.Dimensional testing was performed on the tubing with no issues noted.The reported condition was verified.The cause of the condition could not be determined.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.
Additional Manufacturer Narrative
H10: additionally, there is evidence that solvent was applied to the tubing.A computed tomography (ct) scan identified areas without a surface of contact between the tubing and drip chamber; the channel across both components would result in a leak.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SYSTEM SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18788649
• Report Number: 1416980-2024-00784
• Device Sequence Number: 12836199
• Product Code: FPA
• UDI-Device Identifier: 00085412676623
• UDI-Public: (01)00085412676623
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2024

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 Expiration Date: 02/01/2025
• Device Catalogue Number: 2R8402
• Device Lot Number: R23B04079
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 05/02/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/04/2024; 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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: TOTAL PARENTERAL NUTRITION
• Patient Sex: Unknown