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

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Vomiting (2144); Peritonitis (2252)

Event Date 11/03/2020

Event Type  Injury  

Event Description

A patient contact reported to fresenius that a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler was hospitalized.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, the patient's pd registered nurse (pdrn) reported this patient presented to the emergency department with symptoms of abdominal pain, nausea, vomiting and fever.Peritoneal effluent fluid cultures taken in the emergency department on (b)(6)2020 presented with staphylococcus epidermidis and a white blood cell (wbc) count 81 00/mm3.The patient was diagnosed with peritonitis due to a complication of his pd catheter (not a fresenius product) and sepsis.It was reported the complication of the pd catheter involved touch contamination during ccpd therapy on the liberty select cycler at home.The patient was prescribed intravenous (iv) vancomycin at 1000 mg every day and iv rocephin at 1000 mg every day (duration of medications not reported).The patient required a pd catheter reposition and underwent hemodialysis (hd) on a hospital provided hd machine (brand and model not reported) during this admission.The patient had an uneventful hospital course and was discharged to home in stable condition on (b)(6)2020.It was reported 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 has resumed ccpd therapy on the same liberty select cycler at home post-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: 17535945
• MDR Text Key: 321159388
• Report Number: MW5142837
• 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: 11/23/2020

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