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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/26/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, during a follow up, a patient contact reported to fresenius this peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized with a peritoneal scar tissue infection.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 pd registered nurse, it was reported this patient was hospitalized on (b)(6) 2023 following cloudy peritoneal effluent fluid noted by the patient.Peritoneal effluent fluid cultures and a white blood cell (wbc) count taken in the hospital on (b)(6) 2023 presented with staphylococcus epidermidis in the culture and a wbc count of 3322/mm3.The patient was diagnosed with peritonitis due to a break in aseptic technique during ccpd therapy on the liberty select cycler at home.The pdrn was unaware of any scarring the patient experienced and there was no report from the admitting facility of any peritoneal scarring involved with this event.The patient was prescribed intravenous antibiotics while hospitalized; however, the type, dose, frequency and duration have not yet been reported to the outpatient clinic.The patients pd catheter (not a fresenius product) was removed due to the severity of infection and a central vascular catheter was placed in favor of hemodialysis (hd) on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient recovered from this event and remains asymptomatic.It was confirmed the patient?s peritonitis, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient was discharged to home on (b)(6) 2023 and continues hd therapy on an in-center basis post-discharge.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488564
• MDR Text Key: 320691585
• Report Number: MW5121263
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1