MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT; Set, administration, intravascular

Model Number	1C8507
Medical Device Problem Codes	Filling Problem (1233); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a solution set with duo-vent spike overinfused and exhibited air in line during a propofol infusion programmed at (b)(6)/hour.The reporter stated that the patient required a change of propofol and tubing.The previous medication bag and administration set were removed from the novum pump, and a new medication bag and tubing were prepared.The infusion rate was not changed, and the volume to be infused (vtbi) was adjusted to (b)(6).The infusion was initiated without issue; however, approximately one hour later, the pump alarmed for "air in line." while the alarm was sounding, the bedside nurse reportedly heard a noise suggesting that the pump was still running.Upon assessment, air in line was observed lower in the tubing than expected and the propofol bag was found to be empty.The pump was immediately stopped and the patient was assessed.The reporter stated that the patient's status and vital signs remained stable.There was no report of patient injury or medical intervention associated with these events.No additional information is available at this time.
Additional Manufacturer Narrative
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; parque industrial itabo; carretera sanchez km 18 1/2; haina NA 21426 ; DR 21426
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50692233
• Report Number: 1416980-2026-02913
• Device Sequence Number: 5891765
• Product Code: FPA
• UDI-Device Identifier: 00085412014319
• UDI-Public: (01)00085412014319(17)261028(10)DR24J25048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K243529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 1C8507
• Device Catalogue Number: 1C8507
• Device Lot Number: DR24J25048
• 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: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• 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: Novum IQ LVP pump.; Propofol infusion.
• Patient Sex: Unknown