COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY¿S CLINIC MANAGER (CM) REPORTED THAT ON (B)(6) 2026, A FRESENIUS COMBISET BLOODLINE CAUSED A SALINE BAG TO BACKFILL WITH BLOOD ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. ALL OF THE CLAMPS ON THE SALINE BAG WERE CLAMPED AND BLOOD PULLED FROM THE BLOODLINES BACK INTO THE EMPTY SALINE BAG. THE BACKFILL WAS VISUALLY OBSERVED. THE MACHINE, A FRESENIUS 2008T MACHINE, ALARMED APPROPRIATELY WITH AN AIR DETECTOR ALARM. THERE WERE NO FILLING PROGRAMS ON THE MACHINE. THE CM REPORTED THAT THERE WERE NO QUICK DISCONNECTS ON THE DRAIN LINE AND THAT THE DRAIN LINE LENGTH AND HEIGHT WERE WITHIN SPECIFICATION. THE MACHINE WAS NOT REMOVED FROM SERVICE FOLLOWING THIS INCIDENT AND HAS NOT EXPERIENCED A RECURRENCE OF THE ISSUE. A FRESENIUS DIALYZER WAS ALSO IN USE. FOLLOWING THE INCIDENT, THE PATIENT¿S BLOOD WAS RINSED BACK; HOWEVER, THE BLOOD THAT BACKED UP IN TO THE SALINE BAG COULD NOT BE RETURNED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 50ML. 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 DUE TO THIS EVENT. THE COMPLAINT DEVICE IS NOT 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.