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

Device Problem Malposition of Device (2616)

Patient Problem Constipation (3274)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, a peritoneal dialysis registered nurse [(pd) rn] reported to fresenius technical services this 84-year-old male pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized for constipation and a pd catheter (not a fresenius product) revision.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 pdrn, it was reported this patient was hospitalized on (b)(6) 2022 following drain complications during ccpd therapy on the liberty select cycler at home.It was explained the patient's pd catheter was found in malposition and wrapped up in his abdomen.The patient had concurrent constipation during this event; however, it was affirmed the patient's constipation is a chronic condition that preexisted his start on pd therapy.The patient was able to undergo continuous ambulatory pd (capo) during this admission as capo is the preference for renal replacement therapy in the admitting facility.The patient had a pd catheter revision on (b)(6) 2022 while hospitalized.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2022.It was confirmed the patient's pd catheter issues, catheter procedure, constipation, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient recovered from this event and resumed ccpd therapy on the same liberty select cycler at home post-discharge.(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: 17536318
• MDR Text Key: 321474908
• Report Number: MW5143206
• 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: 05/09/2022

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