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

Device Problems Microbial Contamination of Device (2303); Appropriate Term/Code Not Available (3191)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

The peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler reported to fresenius they experienced an infection requiring removal of their catheter.There was no specific allegation this adverse event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with the patient's pd registered nurse, it was reported this patient was hospitalized following symptoms of abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the hospital presented with fungal growth (genus and species not reported) and a white blood cell (wbc) count of 113/mm3.The patient was diagnosed with peritonitis due to lack of aseptic technique during ccpd therapy on the liberty select cycler at home.The patient was prescribed intravenous (iv) fluconazole and iv metronidazole (dose, frequencies and duration unknown).Due to the severity of the infection, the patient's pd catheter (not a fresenius product) was removed, and a central vascular catheter was placed in favor of hemodialysis (hd) on a hospital provided hd device (brand and model unknown) during this admission.The patient had an uneventful hospital course and was discharged.It was confirmed the patient's peritonitis and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient is recovering from this event and continues hd therapy on an in?center basis following discharge.(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: 17525018
• MDR Text Key: 321145928
• Report Number: MW5131960
• 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: 04/20/2021

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