MAUDE Adverse Event Report: UNKNOWN PD 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 Type  Injury  

Event Description

On 18/mar/2023, fresenius became aware this patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized on (b)(6) 2023.The patient was diagnosed with a fungal infection, which required the removal of the patient's pd catheter (not a fresenius product) and transition to hemodialysis (hd).No additional information was provided during intake.Follow-up with the patient's primary pd registered nurse (pdrn) confirmed the patient presented to the emergency room on (b)(6) 2023 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, value unavailable) were collected, and the patient was admitted/diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin and cefepime (dose, frequency, duration not provided).While hospitalized, the patient encountered drain complications and further evaluation revealed the patient had a fungal infection.The patient underwent the surgical removal of the pd catheter (not a fresenius product) on (b)(6) 2023 and insertion of a permanent hd catheter.The patient's effluent culture returned positive (species/genus not provided), and the patient's vancomycin was discontinued, and replaced with intravenous (iv) gentamycin daily (dose, duration unknown}.The patient remains hospitalized in stable condition and is recovering from the events.The patient transitioned to hd for rrt on (b)(6) 2023 and is tolerating hd without issue.Per the pdrn, the events were unrelated to the patient's utilization of any fresenius product(s) and/or device(s), however the definitive cause of the peritonitis remains unknown.(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: 17488437
• MDR Text Key: 320696398
• Report Number: MW5121136
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1