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

Model Number	HF1400
Health Effect - Clinical Code	Therapy/non-surgical treatment/delayed/prolonged (2520)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Brand new cvvh [continuous veno-venous hemofiltration] set-up with the prismax auto-effluent accessory kit found leaking at the bottom of the drain bag where the tubing drain is connected (closed system, non-luer lock tubing connection).This has been a recurring issue with these drains (not necessarily for same patient).This is in reference to item lot #24c1101 (ref #115370).The entire filter set-up is wasted, and a brand-new filter had to be used, which takes at least 30 minutes to set up, which delays the treatment for this patient.

• Brand Name: PRISMAFLEX SET
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; 25212 w il route 120; round lake IL 60073
• MDR Report Key: 22893944
• Report Number: 22893944
• Device Sequence Number: 8852239
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: (01)07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/19/2025
• Report Date (Section F): 08/19/2025

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 Model Number: HF1400
• Device Catalogue Number: 107142
• Device Lot Number: 24C1101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Date Report Sent to FDA: 08/19/2025