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

Model Number	H93821
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that six (6) repeater pump fluid transfer tube sets had foreign particles in the product container.This was noticed before product use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: h4, h6, h11.H4: the lot was manufactured between 07/03/2023 and 07/04/2023.H11: the actual devices were not available; however, three (03) photographs of the samples were received for evaluation.Visual inspection of the photographs observed particulate matter (pm) embedded in the outside of tubing, in the sealed packaging and on the white spike housing.The pms were described as dark spot/small hair/ particulate.The reported condition was verified.The cause of the condition could not be determined; however, was possibly due to variations in the manufacturing or packaging process.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: 21023323
• Report Number: 1416980-2024-07602
• Device Sequence Number: 8367234
• Product Code: LHI
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520(10)60474312(17)260630
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 08/28/2025

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 Expiration Date: 06/30/2026
• Device Model Number: H93821
• Device Catalogue Number: H93821
• Device Lot Number: 60474312
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 08/28/2025
• 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