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

Device Problems Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Injury  

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) reported that they will have their pd catheter (not a fresenius product) removed for 4 weeks.Follow-up with the patient's pd registered nurse (porn) revealed the patient was diagnosed with peritonitis on approximately (b)(6) 2021, after a peritoneal effluent fluid culture returned positive for staphylococcus epidermis (collection date not provided).The patient was already being treated (outpatient) with intraperitoneal (ip) vancomycin (dosage not provided) when the cultures returned.On (b)(6) 2021, the patient underwent the surgical removal of their pd catheter (not a fresenius product), while concurrently receiving a hemodialysis (hd) catheter (not a fresenius product, type unknown).The porn attributed causality to a touch contamination event; however, the specifics were not provided.The patient transitioned to hd therapy on (b)(6) 2021 and will remain on hd until the first week in (b)(6).The porn stated the patient's liberty select cycler and/or liberty cycler set did not cause or contribute to these events.The patient is tolerating hd well and is going to receive the remaining doses of vancomycin intravenously while undergoing treatment.The patient is recovering from the event and remains in possession of the same liberty select cycler.(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: 17529137
• MDR Text Key: 321110486
• Report Number: MW5136066
• 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: 03/31/2021

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