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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius technical services this male peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized and transitioned to temporary hemodialysis.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with an outpatient porn, it was reported this patient was hospitalized on (b)(6) 2022 due to complications from their pd catheter (not a fresenius product).The hospital course, date of discharge and cause of the patient's pd catheter complications were unknown.Additional attempts were made to acquire further details concerning this hospitalization; however, no additional information was obtained.(b)(6),(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535311
• MDR Text Key: 321163462
• Report Number: MW5142210
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1