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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Fungal Infection (2419)

Event Type  Other  

Event Description

It was reported to fresenius that this patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to peritonitis.No additional information was provided during intake.Followup 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 (results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) vancomycin 1500 mg and ceftazidime 1500 mg daily.However, on (b)(6) 2023 the patient¿s peritoneal effluent fluid culture returned positive for yeast, and the nephrologist ordered the removal of the patient¿s pd catheter (not a fresenius product) on (b)(6) 2023.The patient simultaneously received a temporary hemodialysis (hd) catheter (not a fresenius product) and was transitioned to hd therapy until the peritonitis clears.The patient was discharged on (b)(6) 2023 and began outpatient hd on (b)(6) 2023 without reported issue.The patient is recovering from the events and will receive the remaining antibiotic doses intravenously during hd.The patient resides at a skilled nursing facility and has reported witnessing multiple breaches in aseptic techniques (e.G., lack of ppe, handwashing), while the clinical staff was performing the patient's ccpd causing the peritonitis.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s).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
• MDR Report Key: 17344463
• MDR Text Key: 319294315
• Report Number: MW5119542
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/14/2023

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: 07/17/2023
• Patient Sequence Number: 1