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

Model Number	H938740
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the manufacturing date is unknown and will not be included in the udi.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 2000 ml exactamix empty eva bag leaked from the administration port.The event occurred during compounding.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 between may 28-29, 2024.H11: the actual device and two photographs of the sample were provided for evaluation.Visual inspection was performed on the photo samples, a wet bag was observed with multiple ports, and a leak condition was observed at the highlighted spike port assembly; however, visual inspection of the returned sample did not identify any abnormalities that could have contributed to the reported condition.Functional test was performed and a leak was noted in the tubing, coextruded, spike port assembly of the bag.The reported condition was verified.The cause of the issue was related to manufacturing 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 - 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 ; 2242705355
• MDR Report Key: 25290021
• Report Number: 1416980-2026-01760
• Device Sequence Number: 10023831
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244(17)270430(10)60562048
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900585
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: H938740
• Device Catalogue Number: H938740
• Device Lot Number: 60562048
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 06/26/2026
• 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