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

Device Problem Infusion or Flow Problem (2964)

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

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (pdrn) reported that a peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2020 and discharged (b)(6) 2020 for a non-functional pd catheter.Follow-up with the patient's home program manager (hpm) confirmed the patient was hospitalized on (b)(6) 2020 due to a non-functioning pd catheter.The pm reported the patient is blind, and completely reliant on their patient contact for care.The patient had been experiencing significant drain complications, which the patient contact reported as a liberty select cycler issue(s).The patient contact reportedly fabricated details, leading the home therapy staff to believe the liberty select cycler was causing the patient's drain complications (e.G., reporting the patient drained faster and completely while performing manuals).After being confronted, patient contact admitted to altering certain facts because they did not want the patient to have to "endure" any more surgery.The patient's pd catheter revision was successfully completed on (b)(6) 2020 and the patient was kept overnight to monitor functionality of the new pd catheter.The patient successfully underwent ccpd while hospitalized and was discharged on (b)(6) 2020 in stable condition.The pdrn stated the events were unrelated to the malfunction or deficiency of any fresenius device(s) and/or product(s).(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: 17524909
• MDR Text Key: 321137193
• Report Number: MW5131851
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1