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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/14/2021

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was diagnosed with peritonitis on (b)(6) 2021, relapse peritonitis on (b)(6) 2021, and on-going severe pain.Follow-up with the patient's pd registered nurse (porn) revealed the patient presented to the outpatient home dialysis clinic on (b)(6) 2021 with cloudy effluent fluid and abdominal pain.Although the exact timeline of events is unknown, a peritoneal effluent fluid culture and cell count were obtained, and the cell count was positive for an elevated white blood cell (wbc) count of 496 u/l.Additionally, the peritoneal effluent fluid cultures returned positive for candida parapsilosis.The patient was diagnosed with fungal peritonitis and was treated with diflucan (duration, frequency, route not provided).The porn reported the cause of the patient's fungal peritonitis remains unknown.On (b)(6) 2021, the patient reported awakening with severe pain, going to the emergency room (er) and being diagnosed with peritonitis again.The porn reported the same organism was cultured, and the patient was diagnosed with relapsing fungal peritonitis.There is limited information available regarding the hospitalization, however it appears the patient's pd catheter (not a fresenius product) was removed (date not provided), and the patient transitioned to 'backup' hemodialysis (hd).The patient is currently receiving outpatient hd, and is training to perform home hd.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17537178
• MDR Text Key: 321159933
• Report Number: MW5144058
• 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: 07/08/2021

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