Description of Event or Problem · 0
A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONTACTED (B)(6) TECHNICAL SUPPORT TO REPORT NOT DRAINING (NO ALARM) ON THE LIBERTY SELECT CYCLER. ISSUE OCCURRED IN DRAIN 1 OF 4. CYCLER TOOK ABOUT 2.5 HOURS TO DRAIN ON (B)(6) 2026. PDRN/NURSE IS REQUESTING A CYCLER REPLACEMENT. NURSE IS CALLING FROM CLINIC. PDRN/NURSE STATED THAT THE PATIENT USED THE CYCLER LAST NIGHT AND DID NOT COMPLETE THE TREATMENT. NO FIBRIN. NO CONSTIPATION. THE (B)(6) TECHNICAL SUPPORT REPRESENTATIVE ADVISED TO RESETUP AND CALL BACK FOR LIVE TROUBLESHOOTING. PROVIDED INFORMATION REGARDING THE ESCALATION PROCESS. ON (QSN (B)(4)). PDRN/NURSE STATED THAT WILL DO A HOME VISIT AND EVALUATE PATIENT. PDRN/NURSE STATED THAT THE SCREEN CONTINUED TO FREEZE UP AND REQUESTED THE CYCLER REPLACEMENT. REPLACED CYCLER DUE TO NOT DRAINING (NO ALARM). AT LEAST ONE FULL TREATMENT HAS BEEN COMPLETED ON CURRENT CYCLER. THE (B)(6) TECHNICAL SUPPORT REPRESENTATIVE ISSUE THE CYCLER REPLACEMENT. PATIENT WILL PERFORM CAPD/MANUALS. ESTIMATED TIME ARRIVAL (B)(6) 2026. SCHEDULE PICK UP FOR (B)(6) 2026. SPOKE TO PATIENT¿S PDRN/NURSE (B)(6) FROM (B)(6) ((B)(6) 2026 1:50 PM CDT AT (B)(6) AND CONFIRM THAT THE PATIENT WAS NOT ABLE TO COMPLETE THE TREATMENT ON THE CYCLER ON THE DAY OF THE REPORTED EVENT. PATIENT HAD TO PERFORM CAPD/MANUALS. PDRN/NURSE WAS NOT ABLE TO CONFIRM IF THE CYCLER REPLACEMENT HAS BEEN RECEIVED. PDRN/NURSE STATED THAT PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 DUE TO A PD CATHETER MALFUNCTION. PATIENT¿S CATHETER WILL BE REPLACED. PDRN/NURSE STATED THAT PATIENT IS NOT PERFORMING ANY TREATMENT. PATIENT WILL RETURN TO THE PD TREATMENT UNTIL THE CATHETER REPLACEMENT IS DONE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).