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

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

The peritoneal dialysis (pd) patient contacted fresenius and reported having a drain complication during pd treatment with the liberty select cycler.The patient's pd nurse was aware of the issue and stated the patient had a large clot (fibrin sheath) removed from the pd catheter (not a fresenius product) approximately 2 weeks prior.The nurse confirmed the patient has had build-up of fibrin in the pd catheter and that the patient was using heparin, per standing orders, to mitigate fibrin formation.The nurse confirmed the patient did not have any adverse effects from use of any fresenius device, or product and completes treatment.(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: 17526859
• MDR Text Key: 321079460
• Report Number: MW5133796
• 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: 03/11/2022

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