MAUDE Adverse Event Report: PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Peritonitis (2252); Fungal Infection (2419); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 06/23/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius customer service this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized with peritonitis.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient¿s pdrn, it was reported this patient was hospitalized on (b)(6) 2023 following fever, coughing and upper respiratory congestion.The patient complained of cold-like symptoms approximately one week prior to hospitalization.Cloudy peritoneal effluent fluid was noted by hospital staff on the morning of (b)(6) 2023 following the patient¿s ccpd treatment on a hospital provided cycler (unknown brand and model).Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with candida albicans and wbc count of 2844/mm3.The patient was diagnosed with peritonitis due to unknown etiology.It was explained the patient more than likely contaminated his pd catheter (not a fresenius product) in the environment of an upper respiratory infection; however, there was no report of a sputum culture result in the patient¿s hospital discharge paperwork, so the organism could not be matched to the peritonitis pathogen.The patient was prescribed oral fluconazole at 200 mg daily for two weeks and other antibiotics while hospitalized (unknown types, routes, dosages and frequency).The patient¿s pd catheter was removed due to the nature of infection and a central vascular catheter was placed in favor of hemodialysis (hd) for renal replacement therapy.The patient underwent hd therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2023.It was affirmed the patient¿s upper respiratory infection and associated symptoms were unrelated to pd therapy.Additionally, it was confirmed the patient¿s peritonitis infection, and the associated hospitalization were not due to a deficiency or malfunction or any fresenius product(s) or device(s).The patient will continue hd therapy on an in-center basis starting on (b)(6) 2023 with plans to resume ccpd therapy once cleared by his physician.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).File #: (b)(4).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• MDR Report Key: 17279179
• MDR Text Key: 318617422
• Report Number: MW5119174
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1