AK 96 MACHINES
Received Jul 22, 2026 · Event occurred Jun 22, 2026
Report 9616026-2026-00098 · MDR key 25908388
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Vantive Us Healthcare LlcModel number
NACatalog number
114362
Lot number
NA
Product problems
- Inadequate Ultra Filtration
Patient
Not reported
- High Blood Pressure/ Hypertension
- Weight Changes
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN ULTRAFILTRATION EVENT OCCURRED DURING HEMODIALYSIS THERAPY WITH AN AK 96 MACHINE. ONE HOUR AFTER TREATMENT WAS STARTED, AN ALARM OCCURRED ON THE MACHINE DURING SELF-CALIBRATION. THE ULTRAFILTRATION PARAMETERS WERE CHECKED AND NOTED TO BE WITHIN NORMAL RANGE. THE ALARM COULD NOT BE CLEARED. THE PATIENT EXPERIENCED CHEST TIGHTNESS AND ELEVATED BLOOD PRESSURE. THE MACHINE WAS REPLACED AND DIALYSIS WAS RESUMED. THE POST-THERAPY PATIENT WEIGHT WAS FOUND TO BE A WEIGHT GAIN OF 2.3KG. NO ADDITIONAL INFORMATION IS AVAILABLE.