MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX; SET, I.V. FLUID TRANSFER

Model Number	H938175
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 a vented micro-volume inlet had particulate matter which was described as 'dark markings on the spike'.This was noticed during setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6 (update codes), h11.H4: the lot was manufactured july 2025.H11: the actual device and photos of the sample were provided for evaluation.Visual inspection was performed on the actual sample which identified dark spot on the spike port connector inside the plastic packaging material near the tubing of the inlet.Visual inspection of the photo did not easily identify a dark spot on the spike port connector.The reported condition was verified.The cause of the condition could not be determined; however, likely inherent to contamination during the manufacturing and or packaging process.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: EXACTAMIX
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLASTICOS Y MATERIAS PRIMAS PYMPSA; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 24349474
• Report Number: 1416980-2026-00592
• Device Sequence Number: 11970939
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806(10)804035(17)280708
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K002705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: H938175
• Device Catalogue Number: H938175
• Device Lot Number: 804035
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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