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

Model Number	H938737
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an exactamix® 250 ml eva tpn bag leaked at the membrane port.The issue was noticed during setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: h4: the lot was manufactured between november 29-december 1, 2024.H11: the actual device was not available; however, a video of the sample was provided for evaluation.Visual inspection was performed and the reported issue of leakage was identified from the administration spike port bonding area.The reported condition was verified.The cause of the issue could not be determined; however, the cause was most likely due to inadequate, or lack of cyclohexanone applied to the spike port cap tube when it was inserted into the spike port during the manufacturing process causing an incorrect bonding.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
Additional information: d9, h3, h6(update codes), h11.H11: the device was received for evaluation.The reported issue of leakage was identified by initial visual inspection of the returned sample, as leakage of clear tpn solution into the outer pouch was observed.Functional testing was performed and leak was noted from the administration spike port bonding area during testing.The reported condition was verified.The cause of the issue could not be determined; however, the cause was most likely due to inadequate, or lack of cyclohexanone applied to the spike port cap tube when it was inserted into the spike port during the manufacturing process, causing an incorrect bonding in the returned sample.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 ; 2242705355
• MDR Report Key: 24553515
• Report Number: 1416980-2026-00891
• Device Sequence Number: 13071416
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213(10)60608119(17)271031
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: H938737
• Device Catalogue Number: H938737
• Device Lot Number: 60608119
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 04/22/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/20/2026
• 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