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); Peritonitis (2252); Constipation (3274)

Event Date 07/22/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient went to the hospital and was diagnosed with peritonitis.Upon follow up with the patient's pd registered nurse (porn), it was reported this patient presented to the outpatient clinic with abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6) 2021 presented with candida parapsilosis and cronobacter sakazakii and a white blood cell (wbc) count of 197 /mm3.The patient was diagnosed with peritonitis as a complication from constipation and intra-abdominal sources.The patient was not initially hospitalized for this event and prescribed intraperitoneal ceftazidime at 2000 mg every day for three weeks.The patient was hospitalized on (b)(6) 2021 following a worsening of symptoms caused by the persisting peritonitis infection.During the hospitalization, the patient had the pd catheter (not a fresenius product) removed and a central vascular catheter (cvc) placed at the beginning of this admission in favor of hemodial.Ysis (hd) therapy.The patient was able to undergo hd for renal replacement therapy for the duration of the admission.The patient was given both antibiotic and anti-fungal medications while hospitalized (unknown types, routes, dosages, frequencies and durations).The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.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 continues hd therapy on an in-center basis post-discharge.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(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: 17534614
• MDR Text Key: 321167823
• Report Number: MW5141515
• 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: 08/17/2021

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