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

Model Number	H938751
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	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an exactamix vented, micro-volume inlet had foreign matter in an unspecified location.The foreign matter was discovered during setup prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to d4: unique identifier (udi).Additional information: h11: the actual device was received for evaluation.A visual inspection of the returned sample showed dark spot on the white connector.The reported condition was verified.The cause of the condition was determined to be related to the manufacturing or packaging process, as the particulate matter observed was either enclosed in the returned sealed product sample packaging or embedded in the product tubing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to h6 (update codes) and h11.H11: the cause of the condition could not be determined.However, was possibly related to manufacturing process.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 - AVAILMED S.A. DE C.V. - SP021332; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22835597
• Report Number: 1416980-2025-04244
• Device Sequence Number: 9838305
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K903159
• 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,Followup
• Report Date (Section B): 02/25/2026

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: H938751
• Device Catalogue Number: H938751
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 02/03/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/03/2025; 02/25/2026
• 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