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

Model Number	H93811
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
E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) sterile repeater pump tube sets leaked between the clamp (pump connectors) and tubing.This occurred during compounding.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction to e1: initial reporter e-mail (update).Additional information: d9, h3, h4, h6(update codes), and h11.H4: the lot was manufactured between 15 september 2025 and 17 september 2025.H11: two(2) actual devices and three (3) photographs of the sample were received for evaluation.Visual inspection of photos and returned samples did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed using tap water via a known, properly functioning repeater pump on samples 1 and 2.Leakage was observed in sample 1 due to tubing being detached from the blue connector.No visible leaks were observed in sample 2, the whole tubing set was intact.The reported condition was verified in sample 1.The cause of the condition 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.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): 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: 24461057
• Report Number: 1416980-2026-00759
• Device Sequence Number: 21324408
• Product Code: LHI
• UDI-Device Identifier: 00085412475721
• UDI-Public: (01)00085412475721(10)60679212(17)280831
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 60679212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/04/2026
• 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