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

Model Number	H938741
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an exactamix 3000 ml eva (ethylene-vinyl acetate) tpn (total parenteral nutrition) bag leaked.The issue was further described as, "leakage was observed from the ergonomic spout of the bag".This was observed prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: device manufacture date ¿ the lot was manufactured between march 21-24, 2024.H11: the device and photographs were returned for evaluation.A visual inspection was performed on the actual sample, and the reported leakage was not easily identified.The returned photographs were reviewed, and it was noted that there was leakage from the administration spike port bonding area.Functional testing was performed, and it was noted that there was leakage from the spike port bonding area.The reported condition was verified.The cause of the reported condition could not be determined; however, 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.

• 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 ; 2242702068
• MDR Report Key: 22849870
• Report Number: 1416980-2025-04264
• Device Sequence Number: 4362079
• Product Code: LHI
• UDI-Device Identifier: 00085412477251
• UDI-Public: (01)00085412477251(10)60547549BRK(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: H938741
• Device Catalogue Number: H938741
• Device Lot Number: 60547549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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