MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1C8507
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a solution set with duo-vent spike had significant amount of air in the line.This was observed when the pump was started after an empty fentanyl infusion was changed to a new bag.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, f10/h6: component codes (replace code), h6 (update codes), h11.H11: the actual device and photographs were received for evaluation.Visual inspection of the photographs identified air in the line of the tubing.Visual inspection of the actual device did not identify any abnormalities that could have contributed to the reported condition; all components were correctly placed and according to the specification.Pressure and clear passage testing was performed with no leaks or blockages observed.A pull test was performed and no separation was noted.The sample was functionally tested on an in-lab spectrum pump with no issues observed.The reported condition was verified in the photographs.The cause of the air 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.

• Brand Name: DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22197671
• Report Number: 1416980-2025-03328
• Device Sequence Number: 21139123
• Product Code: FPA
• UDI-Device Identifier: 00085412014319
• UDI-Public: (01)00085412014319(10)DR24J25048(17)261028
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: 1C8507
• Device Catalogue Number: 1C8507
• Device Lot Number: DR24J25048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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: FENTANYL; PUMP
• Patient Sex: Unknown