Description of Event or Problem · 0
IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLIC PD (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER REPORTED TO (B)(6) CUSTOMER SERVICE SHE WAS HOSPITALIZED WITH PD-RELATED COMPLICATIONS. THERE WAS NO SPECIFIC ALLEGATION THAT THESE EVENTS WERE RELATED TO A DEFICIENCY OR MALFUNCTION OF ANY (B)(6) DEVICE(S) OR PRODUCT(S) IN THE INITIAL REPORTING. UPON FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE, IT WAS REPORTED THAT THIS PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOLLOWING DRAIN COMPLICATIONS DURING CCPD ON THE LIBERTY SELECT CYCLER AT HOME. THE PATIENT¿S DRAIN COMPLICATIONS WERE ATTRIBUTED TO THE MALPOSITION OF HER PD CATHETER (NOT A (B)(6) PRODUCT). THE PATIENT¿S PD CATHETER WAS REMOVED, AND A CENTRAL VASCULAR CATHETER WAS PLACED IN FAVOR OF HEMODIALYSIS (HD). THE PATIENT WAS TRANSITIONED TO HD FOR RENAL REPLACEMENT THERAPY ON A HOSPITAL PROVIDED HD DEVICE FOR THE DURATION OF THE ADMISSION. THE PATIENT HAD AN EXTENDED HOSPITAL COURSE DUE TO UNRELATED COMORBIDITIES, AND SHE WAS DISCHARGED HOME ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT¿S PD CATHETER COMPLICATIONS AND ASSOCIATED HOSPITALIZATION WERE NOT DUE TO A DEFICIENCY OR MALFUNCTION OF ANY (B)(6) PRODUCT(S) OR DEVICE(S). THE PATIENT RECOVERED FROM THIS EVENT AS SHE CONTINUES HD THERAPY ON AN IN-CENTER BASIS POST-DISCHARGE. A DECISION WILL BE MADE BY THE PATIENT¿S PHYSICIAN AS TO WHETHER SHE WILL RETURN TO CCPD THERAPY ON THE SAME LIBERTY SELECT CYCLER AT HOME. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).