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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that particulate matter (pm) contamination was observed on the tubing and in the bag of seven (7) exactamix vented, micro-volume inlets.The pm was described as ¿black spots on the tubes and in the bag¿.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 in december 2024.H11: seven devices were received for evaluation.Visual inspection was performed on all the returned samples.Foreign material was observed on all the seven samples, primarily on the white connector area and, in most cases, was located outside the tubing and not within the fluid pathway.Six of the seven samples contained particulate or residue outside the fluid pathway, while one sample contained foreign material within the fluid pathway.The reported condition was verified.The cause of the issue could not be determined; however, the cause was possibly inherent to contamination during the manufacturing 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): ECM - PLASTICOS Y MATERIAS PRIMAS PYMPSA - SP013600; 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: 24430147
• Report Number: 1416980-2026-00688
• Device Sequence Number: 10227533
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806(10)803888(17)271206
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: H938175
• Device Catalogue Number: H938175
• Device Lot Number: 803888
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/30/2026
• 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