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

Model Number	H938724E
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the connection to the bag of an em2400 valve set suddenly broke off during filling while the set was connected to a compounder.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 (update codes), h11.H11: the actual device was received for evaluation.A visual inspection was performed, which identified a detachment between the large bore male connector and outlet pump tube.The reported condition was verified.The cause of the condition could not be determined; however, it may be related to insufficient or missing solvent during the 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 ; 2242705355
• MDR Report Key: 25286446
• Report Number: 1416980-2026-01757
• Device Sequence Number: 13283403
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776(10)60590281(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 06/29/2026

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: Lay User/Patient
• Device Model Number: H938724E
• Device Catalogue Number: H938724E
• Device Lot Number: 60590281
• 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: 06/29/2026
• 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