Description of Event or Problem · 0
ON 20/OCT/2025, FRESENIUS BECAME AWARE THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER FOR RENAL REPLACEMENT THERAPY (RRT) EXPERIENCED A PD CATHETER (NOT A FRESENIUS PRODUCT) TUNNEL INFECTION APPROXIMATELY 3 MONTHS AGO, AND IT RECENTLY ¿OPENED BACK UP.¿ FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT EXPERIENCED A PD CATHETER (NOT A FRESENIUS PRODUCT) TUNNEL INFECTION IN (B)(6) 2025 DUE TO AN UNBLEACHED SHOWER HEAD. THE PATIENT¿S PD CATHETER GREW PSEUDOMONAS WHEN CULTURED (DID NOT PROGRESS TO PERITONITIS) AND WAS TREATED WITH ORAL AND INTRAPERITONEAL (IP) ANTIBIOTICS (DRUG, DOSE, FREQUENCY, DURATION NOT PROVIDED) SIMULTANEOUSLY. THE PDRN CONFIRMED THE TUNNEL INFECTION CLEARED AND HAD BEEN WORKING WELL. ALTHOUGH THE TIMELINE AND SPECIFICS OF THE EVENTS ARE LARGELY UNKNOWN, THE PDRN CONFIRMED THE PATIENT¿S PD CATHETER TUNNEL INFECTION HAD RETURNED AND WAS POSITIVE FOR PSEUDOMONAS. THE PDRN BELIEVES THE SECOND PD CATHETER TUNNEL INFECTION WAS LIKELY THE SAME SOURCE BACK IN (B)(6). THE PATIENT WAS SENT TO THE HOSPITAL ON (B)(6) 2025, WITH THE INTENTION OF REMOVING THE PATIENT¿S PD CATHETER AND PLACING A HEMODIALYSIS (HD) CATHETER. HOWEVER, WHILE BEING TRANSPORTED TO THE HOSPITAL, THE PATIENT¿S CAR WAS STRUCK BY A STUDENT DRIVER CAUSING MULTIPLE BROKEN BONES AND INTERNAL INJURIES. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), HOWEVER GIVEN THE PATIENT¿S EXTENSIVE INJURIES THE FAMILY DECIDED TO PLACE THE PATIENT ON HOSPICE CARE. IT IS BELIEVED THE PATIENT PASSED AWAY ON APPROXIMATELY THE SAME DAY OR EARLY (B)(6) 2025. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE UNRELATED TO ANY FRESENIUS PRODUCT(S), DRUG(S), AND/OR DEVICE(S) MALFUNCTION OR DEFICIENCY. BASED ON THE AVAILABLE INFORMATION, THE LIBERTY SELECT CYCLER CAN BE DISASSOCIATED FROM HAVING A CAUSAL OR CONTRIBUTORY ROLE IN THE SERIOUS ADVERSE EVENTS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A SERIOUS INJURY, PATIENT DEATH, OR OTHER SERIOUS ADVERSE EVENT(S) RELATED TO A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) OCCURRED. THE CATHETER USED BY THE PATIENT IS NOT A FRESENIUS DEVICE. THE MANUFACTURER OF THE CATHETER, AND FURTHER PRODUCT INFORMATION, IS UNKNOWN.