PERITONEAL DIALYSIS CATHETER

Description of Event or Problem

IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) NURSE THAT THIS PATIENT ON PD THERAPY WAS HOSPITALIZED DUE TO AN INFECTION. IN ADDITIONAL FOLLOW-UP, THE PD NURSE STATED THAT THE PATIENT SEEN IN THE OUTPATIENT PD CLINIC ON (B)(6) 2026 FOR SYMPTOMS OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE NURSE STATED THAT THE PATIENT HAD A PD CULTURE OBTAINED IN THE PD CLINIC (THE SAME DAY). THE PATIENT WAS TREATED WITH A DOSE OF VANCOMYCIN (500MG) INTRA-PERITONEAL (IP) FOR SUSPECTED PERITONITIS. PER THE NURSE, ON (B)(6) 2026, THE PATIENT¿S PD CULTURE RETURNED WITH GROWTH OF THE BACTERIA STAPHYLOCOCCUS EPIDERMIS. AS A RESULT, THE PATIENT WAS SENT TO THE HOSPITAL (PER PHYSICIAN ORDERS) DUE TO CONFIRMED PERITONITIS. WHILE HOSPITALIZED, THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY (DETAILS ARE UNKNOWN). ADDITIONALLY, THE PATIENT UNDERWENT REMOVAL OF THE PD CATHETER. SUBSEQUENTLY, ON (B)(6) 2026, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ACCORDING TO THE NURSE, THE PATIENT HAS RESIDUAL RENAL FUNCTION AND IS CURRENTLY NOT RECEIVING ANY DIALYSIS. HOWEVER, IT WAS INDICTED THAT THE PATIENT WILL BE TRANSITIONING TO HEMODIALYSIS MODALITY FOR RENAL REPLACEMENT NEEDS. THE PD NURSE CONFIRMED THAT THE PATIENT DID NOT HAVE ANY FLUID LEAKS OR MALFUNCTIONS WITH (B)(6) PRODUCTS IN RELATION TO THE PERITONITIS EVENT. THE NURSE INDICATED THAT PERITONITIS WAS DUE TO PATIENT BREACH IN INFECTION CONTROL PERTAINING TO THE PD CATHETER (NOT A (B)(6) PRODUCT) WHEREBY THE PATIENT WAS NONCOMPLIANT WITH COVERING THE PD CATHETER EXIT SITE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).