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)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external blood leak was observed at the connection of a prismaflex st150 set and a thermax blood warmer disposable during continuous renal replacement therapy.The volume of blood loss was not known.The set was replaced without the extracorporeal blood being returned to the patient.There was no report of medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6, h11.H11: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photos showed the reported blood leak at the connection between the prismaflex set (male luer connector) and thermax bag (female luer connector).The specific defect that allowed the leakage was not visible.The batch review could not be conducted as the lot number of the disposable was not known.The reported condition was verified.The cause of the condition could not be determined as no further or actual sample testing could be conducted.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; deerfield IL
• Manufacturer (Section G): ECM - LIDER SAS; 92 rue des treize vents; montrevel-en-bresse 01340 ; FR 01340
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24489621
• Report Number: 1416980-2026-00804
• Device Sequence Number: 20087773
• Product Code: KDI
• UDI-Device Identifier: 07332414123932
• UDI-Public: 07332414123932
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: Health Professional
• Device Catalogue Number: 955516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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: PRISMAFLEX SET
• Patient Sex: Unknown