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

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius technical services they underwent a catheter replacement.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient presented to the outpatient clinic on (b)(6) /2021 following a fluid leak from the liberty select cycler that occurred approximately three days prior (exact date unknown).The patient's pd catheter extension set was changed for prophylaxis and the patient did not have a total pd catheter (not a fresenius product) change.There was no report the experienced a serious injury or adverse event and did not require medical intervention beyond prophylactic treatment in response to the fluid leak.The patient continues pd therapy on a newly received liberty select cycler following this event.(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: 17534655
• MDR Text Key: 321433198
• Report Number: MW5141556
• 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: 06/16/2021

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