MAUDE Adverse Event Report: Vantive US Healthcare LLC PRISMAFLEX SET; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	106696
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2026
Type of Reportable Event	Malfunction

• Brand Name: PRISMAFLEX SET
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): Vantive US Healthcare LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MEYZIEU; 7, av. lionel terray, b.p. 126; meyzieu cedex rhone NA 69883 ; FR 69883
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; +1(815)307-2966
• MDR Report Key: 50160442
• Report Number: 8010182-2026-00638
• Device Sequence Number: 9407175
• Product Code: KDI
• UDI-Device Identifier: 07332414064549
• UDI-Public: 07332414064549
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: TC
• PMA/510(K) Number: K041005
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 106696
• 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: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• 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
• Patient Age: 14 MO
• Patient Sex: Unknown
• Patient Weight: 17 LB