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

Device Problem Malposition of Device (2616)

Patient Problem Abdominal Distention (2601)

Event Type  Injury  

Event Description

It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) underwent pd catheter (not a fresenius product) surgery on (b)(6) 2021, and their stomach felt "extended." during follow-up, the pd registered nurse (porn) confirmed the patient underwent a scheduled outpatient pd catheter revision due to mal-positioning.The porn stated the patient's pd catheter "flipped" and required surgical intervention to correct.The surgery was successful, and the patient has recovered from the events.Due to an unrelated issue captured in a separate file, the patient's liberty select cycler was replaced and the patient resumed ccpd therapy without further complaint.Based on the available information, the patient's liberty select cycler has been disassociated from the event(s).There was no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) or product(s) occurred warranting further investigation.C-817627.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: 17534610
• MDR Text Key: 321051831
• Report Number: MW5141511
• 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: 08/06/2021

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