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

Device Problem Complete Blockage (1094)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient contacted fresenius technical support (ts) due to a patient line is blocked message which occurred in fill 4 of their treatment.During the call, the patient reported they had peritonitis and diarrhea.There were no reported allegations that the perionitis and diarrhea was related to issues with a fresenius device or product.During additional follow-up, the patient's nurse confirmed that on (b)(6)2020 the patient was diagnosed with peritonitis.It was reported the patient's pd culture (on (b)(6)2020) grew staphylococcus epidermis.The patient was treated (per clinic algorithm) with intra-peritoneal (ip) vancomycin and fartaz.The nurse stated a repeat pd culture (obtained on (b)(6) 2020) continued to yield staphylococcus epidermis.The patient currently remains on vacomycin per clinic algorithm.Per the nurse, the patient did not have any fluid leaks or any issues with fresenius device or product in relation to the perionitis event.The nurse reported the patient allowed the end of their pd catheter (not a fresenius product) to be exposed which is what caused the peritonitis infection.The nurse stated the patient is being evaluated for biofilm of the pd catheter since the peritionitis has not cleared.It was stated the patient currently continues pd treatments with the same cycler without adverse effect.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534683
• MDR Text Key: 321148537
• Report Number: MW5141583
• 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: 09/18/2020

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