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
Event or Problem Description
It was reported that unspecified quantity of em2400 valve sets leaked during compounding.In one instance, the leakage resulted in contamination of prepared bags containing water-soluble vitamins at port 1.The valve sets were replaced to resolve the issue.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
B3: the events occurred on 16 may, 2025 and 19 may, 2025.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b3, b5, d4 (lot, expiration date, udi), e1 (first name, last name, facility name, reporter address, city, postal code, phone no., e-mail).B3: the event occurred in may, 2025 (update).B5: update the statement "unspecified quantity of em2400 valve sets" to "an em2400 valve set".Remove the statement, "in one instance, the leakage resulted in contamination of prepared bags containing water-soluble vitamins at port 1.The valve sets were replaced to resolve the issue." e1: initial reporter phone no.: (b)(6).
Additional Manufacturer Narrative
Additional information: d9, h3, h4, h6 and h11 h11: one device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The set 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.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): 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: 22212640
• Report Number: 1416980-2025-03371
• Device Sequence Number: 20987758
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776(10)60562096(17)270131
• 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): 01/29/2026

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: H938724E
• Device Catalogue Number: H938724E
• Device Lot Number: 60562096
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 01/21/2026
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/16/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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