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

Device Problems Biofilm coating in Device (1062); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Unspecified Infection (1930); Peritonitis (2252)

Event Date 10/13/2020

Event Type  Injury  

Event Description

A patient on peritoneal dialysis {pd) reported that they had a removal of their pd catheter {not a fresenius product) due to having peritonitis.However, there were no reported allegations that the peritonitis was associated with any issues with fresenius device or product.The patient reported their pd treatments were on hold and did not need pd order.During additional follow-up, the nurse reported that the patient has had an ongoing/recurring peritonitis since (b)(6) 2020.The nurse reported the patient initially had symptoms of abdominal pain.As a result, on (b)(6) 2020, the patient had a pd culture obtained which yielded growth of staphylococcus epidermis.The patient was treated with vancomycin {per clinic protocol) intra peritoneal {ip) for 2 weeks on an outpatient basis {continuing pd treatments).The nurse reported the patient reportedly did not fully recover as the patient had persistent cloudy pd effluent.A repeat pd culture was obtained on (b)(6) 2020 which yielded growth of the same organism, staphylococcus epidermis.Reportedly, the patient was treated with another 2-week course of ip vancomycin (per clinic protocol) and continuing pd treatments.However, the patient continued to have cloudy pd effluent and abdominal pain, according to the nurse.Therefore, on (b)(6) 2020, another repeat pd culture was obtained which continued to have growth of staphylococcus epidermis.The patient was treated with ip vancomycin {per clinic protocol) for an additional 2 weeks.The patient continued pd treatments.On (b)(6) 2021, the patient had a repeat pd culture which revealed ongoing growth of staphylococcus epidermis.Per the nurse, the patient was kept on vancomycin (per clinic protocol) intra-peritoneal for an additional 5 week and continued pd treatments.Subsequently, on (b)(6) 2021, the patient's pd catheter {not a fresenius product) was removed due to biofilm on the pd catheter and the patient was then transitioned to hemodialysis for renal replacement needs.The patient is reportedly continuing unknown antibiotic therapy and is recovering from the peritonitis event.The patient's nurse stated the patient did not have any issues with fresenius device or product in relation to the peritonitis event.The nurse stated the cause of the initial peritonitis was a breach in aseptic technique during the pd exchange.However, the bacteria {staphylococcus epidermis) developed a biofilm on the patient's pd catheter which was implicated as the cause of the ongoing and persistent nature of the peritonitis infection.(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: 17533156
• MDR Text Key: 321158226
• Report Number: MW5140061
• 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: 03/31/2021

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