FX CORAL FX80 HF 24/CS 1.8SA STEAM
Received Jul 7, 2026 · Event occurred Jun 25, 2026
Report 3002807005-2026-00053 · MDR key 25736499
Device
Generic name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer
St. Wendel AgCatalog number
F00012970
Lot number
H8FA17100
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
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 DIALYZER BLOOD LEAK DURING A HEMODIALYSIS (HD) TREATMENT. IN A FOLLOW UP, THE NURSE SAID THE LEAK OCCURRED AT THE END OF THE HEMODIALYSIS (HD) TREATMENT. THE LEAK WAS DESCRIBED AS BEING AN INTERNAL LEAK AND WAS SEEN IN THE DIALYSATE CONNECTOR WASTE LINE WHERE FLUID WAS PINK. BLOOD TESTS STRIPS WERE USED AND TESTED POSITIVE FOR THE PRESENCE OF BLOOD. THE 5008X DIALYSIS MACHINE DID ALARM WITH A BLOOD LEAK ALARM. FRESENIUS BLOODLINES WERE BEING USED.THERE WAS NO DAMAGE NOTED ON THE DIALYZER. THERE WAS PATIENT BLOOD LOSS OF 200ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENT OR MEDICAL INTERVENTION REPORTED. THE PATIENT WAS FINISHED WITH TREATMENT.THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.