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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Fungal Infection (2419)

Event Date 04/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, fresenius became aware this 70-year-old female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with peritonitis.The patient stated her pd catheter (not a fresenius product) was scheduled for removal, and they will transition to hemodialysis (hd) for rrt.During follow-up, the patient's pd registered nurse (porn) confirmed the patient was hospitalized for abdominal pain on (b)(6) 2022 and was diagnosed with a peritoneal yeast (fungal) infection (organism not provided).The patient's pd catheter (not a fresenius product) was surgically removed, and a "tunneled" hd catheter (not a fresenius product) was surgically placed on (b)(6) 2022.The patient was treated with intravenous (iv) antifungals; however, the drug(s), dosage(s), frequency(s), and duration(s) are unknown.The patient underwent their initial hd treatment on (b)(6) 2022 and is scheduled to receive hd again today before being discharged.Due to the patient's transition in modality, the patient will transfer to an outpatient hd clinic closer to their residence.The patient remains hospitalized but is recovering from the events (abdominal pain subsided).The porn reported the cause of the peritoneal infection was a breach in aseptic technique, however no specifics were provided.According to the porn, there was no fresenius device(s) and/or product(s) involvement in relation to the serious adverse events.(b)(6),(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: 17535165
• MDR Text Key: 321164913
• Report Number: MW5142063
• 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: 05/17/2022

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