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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date: the events occurred on (b)(6) 2026 during compounding and on (b)(6) 2026 during testing.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 three (3) sterile repeater pump tube sets leaked between the clamp (pump connectors) and the tubing.One issue occurred during compounding, while two occurred during testing of the affected batch.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, h6(update codes), h11.H4: the lot was manufactured between 15 september 2025 and 17 september 2025.H11: the actual devices were not available; however, two (02) companion sample and a photo were received for evaluation.A visual inspection of the photo showed evidence of leakage.However, visual inspection of companion samples did not identify any abnormalities that could have contributed to the reported condition.A functional testing was performed by loading each of the pump transfer tube sets into repeater pump and pumping programmed volumes of 20ml at medium speed three times, 60ml in total, and sample leakage was observed at the large tubing blue connector on the pvc tubing side.The reported condition was verified on the companion samples.The cause of the condition could not be determined.However, it may be related to the manufacturing process or mishandling of the product by the customer.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: 24471981
• Report Number: 1416980-2026-00777
• Device Sequence Number: 16021686
• Product Code: LHI
• UDI-Device Identifier: 00085412475721
• UDI-Public: 0085412475721
• 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): 06/11/2026

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?: No
• 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: 05/18/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown