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

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Constipation (3274)

Event Type  Injury  

Event Description

On 9/aug/2021, a peritoneal dialysis registered nurse [(pd)rn] reported to fresenius technical services this male pd patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler has a history of constipation and positional pd catheter (not a fresenius product).There was no specific allegation these events were 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 porn, it was reported this patient experienced constipation prior to the start of pd therapy (exact date of diagnosis unknown).It was affirmed pd therapy has not exacerbated the patient's constipation and this issue is unrelated to renal replacement therapy.Additionally, the patient's pd catheter is in malposition due to a migration of their catheter, and they have not experienced a serious injury or adverse event that could potentially cause or contribute to the ma i position of their pd catheter.The patient has not been hospitalized for these events and has not required medical intervention beyond ongoing pd therapy support.It was confirmed the patient's constipation and malposition of their pd catheter were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues pd therapy on a newly received liberty select cycler at home following these events.C-824437.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: 17535833
• MDR Text Key: 321096459
• Report Number: MW5142727
• 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: 08/23/2021

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