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

Model Number	H938740
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).H4: the lot was manufactured between december 8-10, 2024.H11: the seven (7) used bags were evaluated.Visual and functional leak testing was performed which identified one (1) bag with a pin hole leak on the right side of eva bag, one (1) bag with a pin hole leak in front lower part of eva bag, three (3) bags with admin port leaks, and two (2) bags that were torn (cut open from the top).The cause of the damages could not be determined; however, the admin port leak may be due to inadequate or lack of cyclohexanone applied to the spike port cap tube during manufacturing.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.
Event or Problem Description
During evaluation of seven (7) returned exactamix 2000 ml eva tpn bags, leaks and damage (torn) bags were observed.Three (3) bags had leaks originating from administration port, two (2) bags had pin hole leaks, and two (2) bags were found torn.No additional information is available.

• 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: 24533769
• Report Number: 1416980-2026-00867
• Device Sequence Number: 8972119
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244(10)60610746(17)271130
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: H938740
• Device Catalogue Number: H938740
• Device Lot Number: 60610746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• 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