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

Model Number	H938173
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the lot number (10) is unknown; therefore, the udi number only will contain the device identifier (01).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a non-vented high-volume inlet leaked from an unspecified location.This occurred during setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6(update codes), h11.H11: the actual device and a photograph of the sample were provided for evaluation.Visual inspection was performed on the photo sample, and leakage was identified as some liquid droplets were observed; however, during the visual inspection of the returned sample, no defects were observed.Functional testing was performed on the returned sample, and an issue of leakage was observed or encountered during testing.The cause of the issue could not be determined.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 ; 2242705355
• MDR Report Key: 24760367
• Report Number: 1416980-2026-01155
• Device Sequence Number: 21440181
• Product Code: LHI
• UDI-Device Identifier: 00085412475783
• UDI-Public: (01)00085412475783
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: Other
• Device Model Number: H938173
• Device Catalogue Number: H938173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/16/2026
• 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