MAUDE Adverse Event Report: Vantive US Healthcare LLC Prismaflex Sets (HF); Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	107142
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/08/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that approximately fifteen (15) minutes after initiation of continuous renal replacement therapy (crrt) using prismaflex hf set, a patient experienced severe hypotension requiring up to three (3) vasopressors.Anallergic reaction was suspected.After switching to prismaflex st set, the hypotensive episodes reportedly did not recur.It is further reported that the patient passed away, however, the date and cause of death were not provided.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: Prismaflex Sets (HF)
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): Vantive US Healthcare LLC; deerfield IL
• Manufacturer (Section G): BAXTER 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: 50951729
• Report Number: 8010182-2026-00783
• Device Sequence Number: 10348852
• Product Code: KDI
• UDI-Device Identifier: 07332414069315
• UDI-Public: 07332414069315
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 107142
• Device Lot Number: ASKU
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• 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: PrisMax machine.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Male