CATHETER, PERITONEAL

Description of Event or Problem

IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER AND LIBERTY CYCLER SET FOR RENAL REPLACEMENT THERAPY (RRT) CONTRACTED AN INFECTION DUE TO THEIR PD TREATMENT. THE PATIENT¿S PD CATHETER (NOT A (B)(6) PRODUCT) WAS REPORTEDLY REMOVED, AND THE PATIENT TRANSITIONED TO BACKUP HEMODIALYSIS (HD) FOR 21 DAYS TO ALLOW THE PATIENT¿S ABDOMEN TO HEAL. FOLLOW-UP WITH THE PATIENT¿S PD REGISTERED NURSE (PDRN) CONFIRMED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF ABDOMINAL PAIN AND CLOUDY PERITONEAL EFFLUENT FLUID. A PERITONEAL EFFLUENT FLUID CULTURE AND CELL COUNT (WBC = 667 /MM3) WERE COLLECTED, AND THE PATIENT WAS FORMALLY ADMITTED. THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS TREATED WITH INTRAVENOUS (IV) CEFAZOLIN 2000 MG DAILY FOR 14 DAYS. THE PATIENT¿S PERITONEAL EFFLUENT CULTURE RESULT RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS, AND THE PATIENT¿S ANTIBIOTIC REGIMEN WAS CONTINUED. ALTHOUGH THE TIMELINE IS LARGELY UNKNOWN, IT WAS REPORTED THE PATIENT¿S PD CATHETER WAS SURGICALLY REMOVED, AND THE PATIENT TRANSITIONED TO BACKUP HEMODIALYSIS (HD) FOR RRT. THE PATIENT WAS DISCHARGED HOME (DATE NOT PROVIDED) AND HAS RECOVERED FROM THE SERIOUS ADVERSE EVENTS. THE PDRN ATTRIBUTED CAUSALITY TO A PROBABLE TOUCH CONTAMINATION EVENT BASED ON THE ROOT CAUSE ANALYSIS. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY (B)(6) PRODUCT(S) AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. PENDING THE PATIENT¿S RETURN TO CCPD THERAPY, THE PDRN STATED THE PATIENT WILL RESUME UTILIZING THE SAME LIBERTY SELECT CYCLER AS BEFORE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).