OPTIFLUX F160NRe HF 12/CS 1.5SA EBEAM
Received Jul 10, 2026 · Event occurred Jun 29, 2026
Report 0001713747-2026-00279 · MDR key 25782476
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
Ogden Manufacturing PlantCatalog number
0500316E
Lot number
26CU06012
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT A FRESENIUS OPTIFLUX DIALYZER LEAKED FROM THE HEADER DURING PRIMING. THE DIALYZER APPEARED TO BE MALFORMED WHERE THE LINES ATTACH TO THE HEADER. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS ISSUE. THE ACTUAL COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.
Additional Manufacturer Narrative
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.