MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC THERMAX BLOOD WARMER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	955516
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient treatment using a thermax blood warmer, "the connection/snap between the thermax blood warmer set and the prismaflex set breaks and blood starts flowing." treatment was discontinued.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added h6 and h11: the actual device was not available, and the lot number was unknown; therefore, a device analysis could not be completed.No photograph of the sample was provided for evaluation.The reported condition was not verified.The cause of the condition was not determined as no further or actual sample testing could be performed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THERMAX BLOOD WARMER
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): ECM - LIDER SAS; see h11; montrevel-en-bresse 01340 ; FR 01340
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 23383627
• Report Number: 1416980-2025-05281
• Device Sequence Number: 12922839
• Product Code: KDI
• UDI-Device Identifier: 07332414123932
• UDI-Public: 7332414123932
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: Health Professional
• Device Catalogue Number: 955516
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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: PRISMAFLEX SET
• Patient Sex: Unknown