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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support to report a fluid leak from the catheter at treatment complete step 8 on the liberty select cycler.The patient stated they had some bad cramping in their legs and the catheter tubing was wet.The fresenius technical support representative advised the patient to contact their pd nurse as soon as possible.There was no patient harm or adverse event, and no medical intervention was required.(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: 17527469
• MDR Text Key: 321065646
• Report Number: MW5134401
• 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: 02/15/2022

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