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

Model Number	H93811
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a sterile repeater pump tube set leaked from a missing ¿diaphragm¿.This was observed during setup.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4 and h6.H11: the actual device and a photograph were returned for evaluation.The returned photograph was reviewed, and the reported issue of leakage was not easily identified.The actual device was visually inspected, and the reported issue of leakage was not easily identified.Functional testing was performed by loading each of the tube set into a repeater pump and pumping programmed volumes of 20ml at high speed four times and 80ml in total, and the sample had no leaks observed, and whole tubing set is intact.The reported condition was not verified.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: REPEATER
• 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: 24054520
• Report Number: 1416980-2026-00178
• Device Sequence Number: 18647628
• Product Code: LHI
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721(10)60630725(17)280229
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 04/10/2026

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: H93811
• Device Catalogue Number: H93811
• Device Lot Number: 60630725
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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