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

Model Number	2H8603
Medical Device Problem Codes	Filling Problem (1233); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of clearlink system extension sets underinfused during patient infusion.Air was gathering in the filter during priming.Once all the air was eliminated, the patients were not getting the full dose.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph identified air in line which can potentially impact flow.The reported air condition was verified.The cause of the air could not be determined.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; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19812399
• Report Number: 1416980-2024-03794
• Device Sequence Number: 8380218
• Product Code: FPA
• UDI-Device Identifier: 00085412046433
• UDI-Public: (01)00085412046433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: Health Professional
• Device Model Number: 2H8603
• Device Catalogue Number: 2H8603
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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: LIPIDS
• Patient Sex: Unknown