MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2H8486
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that solution would not flow through the filter of a clearlink system non-dehp solution set.This issue was further described as, ¿tpn tubing would not flush through filter ¿ tpn flushed back into bag ¿ normal saline used to clear tubing and also would not flush past filter¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B5: additional information was received which clarified that this event occurred while priming the set.The patient was not connected at the time of this event.There was no patient involvement.H11: the actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specification.Pressure test and clear passage under water were performed, and no issues were observed.Priming was also performed, and no defects were noted.The reported condition was not verified.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h11; see h11; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20354805
• Report Number: 1416980-2024-05424
• Device Sequence Number: 14325801
• Product Code: FPA
• UDI-Device Identifier: 00085412074764
• UDI-Public: (01)00085412074764(10)R24F22086
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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 Model Number: 2H8486
• Device Catalogue Number: 2H8486
• Device Lot Number: R24F22086
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: NORMAL SALINE.; TOTAL PARENTERAL SOLUTION.
• Patient Sex: Unknown