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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Viral Infection (2248); Peritonitis (2252); Pancreatitis (4481)

Event Date 02/15/2022

Event Type  Injury  

Event Description

A patient representative contacted fresenius technical support on behalf of an end stage renal disease (esrd) patient requesting assistance with cycler drain complication alarm.While consulting the pdrn it was reported that the patient had long drain times and was being treated for peritonitis.Upon follow up the pdrn reported the patient presented to the emergency room (b)(6) 2022 with abdominal pain.A peritoneal effluent fluid culture and cell count were collected, and the patient was diagnosed with peritonitis.The patient's peritoneal effluent culture result returned positive for staphylococcus epidermidis, and causality was assigned to an unspecified touch contamination event involving poor hand hygiene.Upon admission the patient was diagnosed with covid-19 and pancreatitis.The pdrn reported the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.The patient is being treated with intravenous {iv) vancomycin, ceftazidime, and cefazolin and remains hospitalized while recovering from the events.While hospitalized the patient's pd catheter, a non-fresenius product, was surgically removed and the patient was transitioned to hemodialysis (hd).The patient remains hospitalized and is tolerating hd well.(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: 17533447
• MDR Text Key: 321163004
• Report Number: MW5140351
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1