OPTIFLUX F180NRe HF 12/CS 1.7SA EBEAM
Received Jul 6, 2026 · Event occurred Jun 20, 2026
Report 0001713747-2026-00262 · MDR key 25720005
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500318E
Lot number
26AU07013
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
Description of Event or Problem
A NURSE REPORTED A LEAK ASSOCIATED WITH A HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, THE NURSE SAID THE LEAK WAS RECOGNIZED PRIOR TO HEMODIALYSIS (HD) TREATMENT. SALINE WAS LEAKING OUT OF THE HANSEN HOOK UPS AND ONTO THE FLOOR. FRESENIUS 2008T MACHINE AND FRESENIUS BLOODLINES WERE USED. THERE WAS NO ALARM AND NO ALARM WAS EXPECTED. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT AS THE PATIENT WAS NOT INVOLVED YET.THE PATIENT WAS ABLE TO HAVE A TREATMENT ON A SAME MACHINE WITH NEW SUPPLIES. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.