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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chest Pain (1776); Peritonitis (2252); Abdominal Distention (2601)

Event Date 05/12/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6)2022, a peritoneal dialysis registered nurse [(pd}rn] reported to fresenius technical services this pd patient on continuous cyclic pd (ccpd} therapy on the liberty select cycler experienced peritonitis.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 pdrn, it was reported this patient was admitted to the hospital for chest pain on (b)(6)2022.There was no indication the patient's chest pain was related to the peritonitis event, the performance of any fresenius product(s} or device(s} or pd therapy in general.The patient experienced abdominal bloating during ccpd therapy on the liberty select cycler prior to this admission.Peritoneal effluent fluid cultures taken in the hospital on (b)(6)2022 presented with streptococcus mitis and a white blood cell (wbc) count of 22,889/mm3.The patient was diagnosed with peritonitis due to inappropriate infection control during pd therapy.It was explained the patient ran out of alcavis wipes to clean his catheter during pd therapy and alternatively, was using an inappropriate cleaning agent.The patient was prescribed intraperitoneal (ip} diflucan at 200 mg daily for three weeks and ip ceftazidime at 2000 mg daily for three weeks.The patient was able to undergo ccpd therapy on a hospital provided cycler (unknown brand and model} for the duration of the admission.The patient recovered from this event and was discharged to home on (b)(6)2022.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}.Follow up peritoneal effluent fluid cultures taken in the outpatient clinic on (b)(6)2022 presented no growth, evidencing a resolved infection.The patient continues ccpd therapy on the same liberty select cycler at home post-discharge with persisting drain complications.The patient is scheduled for a pd catheter (not a fresenius product} evaluation as his catheter is the suspected cause of drain complications.(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: 17527927
• MDR Text Key: 321146862
• Report Number: MW5134858
• 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: 05/24/2022

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