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

Model Number	H938724
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
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 an em2400 valve set had a leaky port 5 that causes air in line and bubbles.This occurred during compounding potassium phosphate.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, h6(update codes), h11.H4: the lot was manufactured between august 9-10, 2025.H11: the actual device was not available; however, five companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed on the returned companion sample, and the reported issue was identified.Functional testing was performed on one companion sample and while performing the set-up wizard steps and the direct entry compounding cycle, bubbles were observed or encountered during testing.The sample was evaluated the compounding cycle was completed with bubble detected alarms or errors occurring on port 5.The issue of bubbles was not verified during prime and verify, ui flush or after the pump calibration process.However, a bubble was detected during the direct entry compounding cycle during testing.The reported condition was verified.The cause of the bubble could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.However, reports of bubbles in the line are not associated with a contamination or accuracy issue and are not likely to cause or contribute to a death or serious injury.The issue is unlikely to cause or contribute to serious injury.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: 24468129
• Report Number: 1416980-2026-00769
• Device Sequence Number: 15829212
• Product Code: LHI
• UDI-Device Identifier: 00085412477183
• UDI-Public: (01)00085412477183(10)60668647(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/06/2026

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: H938724
• Device Catalogue Number: H938724
• Device Lot Number: 60668647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown