POLYFLUX
Received Jul 22, 2026 · Event occurred Mar 25, 2026
Report 9611369-2026-00100 · MDR key 25906896
Device
Generic name
Dialyzer, Capillary, Hollow Fiber
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
112466C
Lot number
5-3852-H-01
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Male
- Hypersensitivity/Allergic reaction
- Palpitations
Narrative
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT 30 MINUTES AFTER STARTING TREATMENT WITH A POLYFLUX 170H DIALYZER, THE PATIENT EXPERIENCED PALPITATIONS AND CHEST TIGHTNESS. THE PATIENT WAS TREATED WITH INTRAVENOUS DEXAMETHASONE (5 MG), AND OXYGEN WAS ADMINISTERED; HOWEVER, THERE WAS NO IMPROVEMENT. TREATMENT WAS DISCONTINUED AND THE DIALYZER WAS REPLACED. IT WAS REPORTED SYMPTOMS IMPROVED AND "ANTI-ALLERGY TREATMENT" WAS ADMINISTERED. THE PATIENT'S RECOVERY WAS MONITORED. NO ADDITIONAL INFORMATION IS AVAILABLE.