AK 98 MACHINES
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 9616026-2026-00090 · MDR key 25725100
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
110655
Lot number
NA
Product problems
- Inadequate Ultra Filtration
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AN ULTRAFILTRATION EVENT OCCURRED DURING HEMODIALYSIS THERAPY WITH AN AK 96 MACHINE, DESCRIBED AS "INACCURATE DEHYDRATION OCCURRING MULTIPLE TIMES". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.