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

Model Number	H938724E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the events occurred in may 2025.E1: initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that five (05) em2400 valve sets leaked.The issue was further described as, "leak on the valve strip".This occurred during use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6 and h11.H4: the device was manufactured between 04nov2022 and 07nov2022.H11: five devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sets underwent functional testing by installing the valve set sample on a compounder and performing the system functional test procedure for the main module compounding system.This included the setup wizard which further included prime, verify, automated occlusion self-test, pump calibration, and direct entry compounding cycles with a 70% dextrose solution set to port 19 and sterile water universal ingredient to port 24 for testing.No calibration errors or leaks were encountered during testing.The reported condition was not verified in any of the returned samples.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.
Additional Manufacturer Narrative
Correction to d9, h3, h6 and h11.D9 and h3: remove the selections.H6: type of investigation (update).H11: the actual devices were not available; however, five (5) companion samples were received for evaluation.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): AVAILMED; 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: 22879855
• Report Number: 1416980-2025-04315
• Device Sequence Number: 9480478
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776(10)60410240(17)250731
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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 Expiration Date: 07/31/2025
• Device Model Number: H938724E
• Device Catalogue Number: H938724E
• Device Lot Number: 60410240
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 03/03/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 01/29/2026; 04/02/2026
• 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