COMBISET ACCESS FLOW REVERSE CON TWISTER
Received Mar 24, 2026 · Event occurred Mar 20, 2026
Report 0008030665-2026-00556 · MDR key 24673845
Device
Generic name
Accessories, Blood Circuit, Hemodialysis
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
03-2794-0
Lot number
25PR01025
Product problems
- Fluid/Blood Leak
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
A USER FACILITY¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED ONE AND A HALF HOURS AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE BLOODLINE. THERE WERE NO ISSUES DURING PRIMING AND NO LOOSE CONNECTIONS. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300ML. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE 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.