CATHETER, PERITONEAL

Description of Event or Problem

THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE OF PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL THERAPY. THE PATIENT EXPERIENCED PERITONITIS ON (B)(6) 2013 AND WAS HOSPITALIZED ON THE SAME DAY. THE NURSE STATED THE CAUSE OF THE PERITONITIS WAS THE CATHETER LEAKING. ON AN UNKNOWN DATE, THE PD EFFLUENT WAS ANALYZED. IT WAS UNKNOWN IF THE PD EFFLUENT SAMPLE WAS FROM BEFORE STARTING ANTIBIOTICS. A CULTURE WAS PERFORMED BUT THE RESULTS WERE UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN WHILE IN THE HOSPITAL. THE NURSE STATED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2013 FOR A LEAKING CATHETER AND CAME OUT WITH PERITONITIS. THE PATIENT RECOVERED FROM THIS EVENT AND WAS DISCHARGED ON (B)(6) 2013. THE PD THERAPY WAS ONGOING WHILE IN THE HOSPITAL. PATIENT INJURY REPORTED: YES. MEDICAL INTERVENTION REQUIRED: YES, (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).