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

Device Problem Improper Flow or Infusion (2954)

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

Event Type  Other  

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support requesting a replacement liberty select cycler for a peritoneal dialysis (pd) patient.The patient was not draining.The pdrn stated the patient was on vacation and went to the hospital due to not being able to drain.The patient had the pd catheter (not a fresenius product) removed for unknown reasons.Additional information that was obtained through the home therapy program manager documented that the patient had the pd catheter removed and would not be returning from vacation or returning to pd therapy as they were staying with family.The cycler was scheduled to be picked up and returned.The replacement cycler was no longer needed.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to add'l documents in i2k.

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• MDR Report Key: 17279146
• MDR Text Key: 318613053
• Report Number: MW5119173
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1