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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 01/22/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had an exit site infection.Follow-up with the patient's pd registered nurse (porn) revealed the patient presented to the outpatient home dialysis clinic on (b)(6) 2021, with drain complications and abdominal pain.Peritoneal effluent fluid cultures were obtained, and the patient was started on intraperitoneal (ip) vancomycin 2000 mg every 5 days and ip gentamycin 160 mg daily.On (b)(6) 2021, the cultures returned positive for staphylococcus aureus, pseudomonas aeruginosa, and corynebacterium.Upon receipt of the culture results, the nephrologist ordered an outpatient surgery consult, to see if the pd catheter could be "saved." the patient was seen by the surgeon on (b)(6) 2021 and it was determined the pd catheter infection was too severe to clear without removal.Therefore on (b)(6) 2021, the patient underwent an outpatient surgical procedure to remove the infected pd catheter and surgically place a hemodialysis (hd) catheter (not a fresenius product).On 6/feb/2021 the patient transitioned to "back-up" hd until the patient's infection has cleared.The porn attributed causality to improper hand hygiene and failing to wear the proper personal protective equipment (ppe).The porn reported the events were unrelated to any fresenius device(s) and/or product(s).The patient is tolerating hd well and is recovering from the events.(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: 17537512
• MDR Text Key: 321148572
• Report Number: MW5144390
• 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: 03/01/2021

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