PD CATHETER/ LIBERTY SELECT CYCLER

Description of Event or Problem

A PERITONEAL DIALYSIS (PD) PATIENT'S WIFE CONTACTED (B)(6) TECHNICAL SUPPORT TO REPORT THAT THE LIBERTY SELECT CYCLER ALARMED WITH A NOTICE: DRAINING SLOWLY MESSAGE AND FOR OPERATIONAL QUESTIONS. MESSAGE OCCURRED IN DRAIN 1 (5ML OF 2000ML). PATIENT WAS CONNECTED DURING INCIDENT. PATIENT IS NOT EMPTY. NOTHING WAS ENTERED DURING SETUP FOR DAYTIME MANUAL EXCHANGE. THE BLUE PIN THAT IS CLOSEST TO THE PATIENT WAS NOT PUSHED IN. PATIENT LINE (PL) WAS NOT KINKED. AIR BUBBLES WERE NOT DISCOVERED. FIBRIN WAS NOT DISCOVERED. PATIENT WAS NOT CONSTIPATED. PL CLAMP WAS OPENED. THE (B)(6) TECHNICAL SUPPORT REPRESENTATIVE ASSISTED PATIENT WITH TECHNICAL SUPPORT STEP ALARM REOCCURRED. PATIENT'S WIFE STATED SHE WILL MANUALLY DRAIN PATIENT AND WILL RE-SETUP CYCLER AND RECONNECT PATIENT TO SEE IF HE CAN DRAIN ON CYCLER. UPON FOLLOW UP, IT WAS CONFIRMED THAT PATIENT WAS NOT ABLE TO COMPLETE TREATMENT ON THE REPORTED DAY WITH THE CYCLER AND DID NOT TRY CAPD/MANUALS. NURSE STATED THAT PATIENT WAS ADMITTED THAT SAME DAY, (B)(6) 2025 FOR REVISION OF HIS CATHETER AND STATED THAT PATIENT WAS PRESENTING A CATHETER OCCLUSION SO PATIENT WAS INTERVENED TO FIX HIS PD CATHETER. THE FOLLOWING DAY (B)(6) 2025 PATIENT UNDERWENT FOR A HEMODIALYSIS CATHETER. PATIENT HAS BEEN DOING HEMODIALYSIS IN THE MEANTIME THE PROCEDURE WITH THE PD CATHETER HEALS. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED, MEDICAL INTERVENTION WAS REQUIRED, HOWEVER NOT RELATED TO THE PATIENT'S TREATMENT OR ANY USE OF THE (B)(6) PRODUCTS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).