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

Model Number	2H8480
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Protective Measures Problem (3015); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that two (2) clearlink system non dehp solution sets had defects preventing priming of the devices.One (1) set had constant air bubbles which resulted in an occlusion alarm on an unspecified pump during priming with amino acids.While the filter was inspected, a gap was noticed at the area proximal to the bag; further described as "when looking at other tubing this area to filter looks different" and "it sounds like air escaping" when a syringe was used to push and pull.Another filter was pulled which appeared to have the same defect.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction d4 expiration date: updated to n/a.Additional information: d9, h4, h6, h11.H11: one (1) actual device and a companion sample were provided for evaluation.Visual inspection of the returned samples did not identify any abnormalities that could have contributed to the reported condition.Pressure testing, clear passage under water testing, and priming testing were performed, and there were no defects observed that could generate the reported condition.Functional testing was performed connected to a spectrum iq pump with a flow rate of 125 ml per hour, and no defects were observed that could generate the reported condition.The reported condition was not verified.The second device was not received for evaluation; therefore, a device analysis could not be completed.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 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: 20027756
• Report Number: 1416980-2024-04343
• Device Sequence Number: 8591095
• Product Code: FPA
• UDI-Device Identifier: 00085412048499
• UDI-Public: (01)00085412048499(10)R23G26024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153158
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 2H8480
• Device Catalogue Number: 2H8480
• Device Lot Number: R23G26024
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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
• Patient Sex: Unknown