Description of Event or Problem · 0
A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED TO (B)(6) CUSTOMER SUPPORT THAT THE PATIENT IS IN THE HOSPITAL DUE TO FLUID OVERLOAD. THE PATIENT HAS NOT BEEN DOING TREATMENTS. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE PATIENT¿S PDRN. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2025 DUE TO ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF FLUID OVERLOAD, PERITONITIS, AND ABDOMINAL PAIN. THE PATIENT WAS NOT IN TREATMENT AT THE TIME OF THE EVENT. THE PATIENT WAS HOMELESS AND HAD MISSED FIVE TREATMENTS PRIOR TO THE HOSPITALIZATION. THE PATIENT HAD REFUSED TO CHANGE MODALITY TO HEMODIALYSIS (HD) AND WOULD NOT ANSWER THE CALLS AND TEXTS FROM THE PDRN OR SOCIAL WORKER WHEN HE MISSED THE PD TREATMENTS. THE PATIENT CHECKED OUT FROM PROVIDENCE EAST HOSPITAL ON (B)(6) 2025 AGAINST MEDICAL ADVICE (AMA). THE PATIENT WAS THEN ADMITTED ON THE SAME DATE TO (B)(6) HOSPITAL. THE CAUSE OF THE FLUID OVERLOAD WAS THE PATIENT NOT COMPLETING PD TREATMENTS. THE PERITONITIS WAS A CONTINUATION FROM AN EPISODE THAT WAS INITIALLY DIAGNOSED ON (B)(6) 2025 (B)(4). THE PATIENT NEVER COMPLETED THE ANTIBIOTIC REGIMEN RESULTING IN THE PERITONITIS NOT RESOLVING. THE CULTURE RESULTS WERE THE SAME SHOWING METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE ANTIBIOTIC THERAPY WAS NOT AVAILABLE. THE PATIENT¿S PD CATHETER (NOT A (B)(6) PRODUCT) WAS PULLED ON (B)(6) 2025 DUE TO THE RELAPSING PERITONITIS. THE PATIENT STARTED HEMODIALYSIS (HD) ON (B)(6) 2025. THE HOSPITALIZATION WAS UNRELATED TO ANY (B)(6) DEVICE(S) OR PRODUCT(S) AND/OR THEIR DIALYSIS THERAPY. THE PATIENT REMAINS HOSPITALIZED. THE CAUSE OF THE INITIAL PERITONITIS DIAGNOSIS WAS TOUCH CONTAMINATION. THE REPORTED EVENT IS RELATED TO THE USE OF A PD CATHETER (NON- (B)(6) PRODUCT). THE MANUFACTURER OF THE CATHETER, AND FURTHER PRODUCT INFORMATION, IS UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).