MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8546
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clearlink system, non-dehp continu-flo solution set leaked at the y-site port despite the green alcohol caps being in place.This was noticed during use.The device contained total parenteral nutrition.The line was changed to resolve the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).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
H11: two (2) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including pressure testing, clear passage under water testing, and priming testing, and the results were satisfactory, no defects were observed that could generate the reported condition.Usage testing by gravity was performed, and a static leak at the second clearlink was identified in sample #1 and no defects were observed in sample #2.A usage test with a spectrum iq pump was performed and no defects were observed.A water referee back pressure test was performed, and no defects were observed.An autopsy on the second clearlink of sample #1 was performed, and it was observed that there were slight marks at the components.The reported condition was verified in the first sample.The cause of the reported condition was a manufacturing issue.The reported condition was not verified in the second sample.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to a3a, e4, h10, and h11: h11: should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to g2: report source and d4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).Correction to h6 and h11: h6: remove 'c19' and 'd14'.H11: update the sentence "two (2) actual devices were received for evaluation" to "the actual device was received for evaluation' and remove "and no defects were observed in sample #2.A usage test with a spectrum iq pump was performed and no defects were observed.A water referee back pressure test was performed, and no defects were observed." should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20369514
• Report Number: 1416980-2024-05455
• Device Sequence Number: 20552467
• Product Code: FPA
• UDI-Device Identifier: 00085412565699
• UDI-Public: (01)00085412565699
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/18/2025

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: 2R8546
• Device Catalogue Number: 2R8546
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 11/05/2024; 03/21/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/11/2024; 12/02/2024; 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TPN.
• Patient Sex: Unknown