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

Device Problems Contamination (1120); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fever (1858); Peritonitis (2252)

Event Date 05/21/2021

Event Type  Injury  

Event Description

On 21/may/2021 fresenius became aware this patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) since (b)(6) 2020, was taken to the hospital on (b)(6) 2021 for drain complications and fever.Follow-up with the patient's pd registered nurse (porn) confirmed the patient was hospitalized on (b)(6) 2021 for drain complications and fever.A pd catheter (not a fresenius product) revision was performed due to the catheter having migrated out of position.The surgery was successful and the patient was admitted for evaluation of the catheter's function during pd therapy.On (b)(6) 2021, the patient reportedly complained of abdominal pain and a peritoneal effluent culture was obtained.The patient continued to undergo ccpd until (b)(6) 2021, when the patient encountered drain complications.On (b)(6) 2021, the peritoneal effluent fluid cultures returned positive for staphylococcus aureus and the patient was diagnosed with peritonitis.It was also reported the patient was found to have "pockets of puss" within the peritoneum.The patient's pd catheter was surgically removed on (b)(6) 2021 and a tunneled permanent hemodialysis (hd) catheter (not a fresenius product) was placed.The patient was transitioned to hd therapy and was treated with intravenous (iv) vancomycin 1500 mg (frequency not provided).The porn states the patient remains hospitalized and will remain on hd for rrt for the foreseeable future.The cause of the peritonitis was attributed to a cross contamination event with a wound infection from the patient's below the knee amputation.The porn stated the events were unrelated to any fresenius device(s) and/or product(s) deficiency or malfunction.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17528201
• MDR Text Key: 321132904
• Report Number: MW5135132
• 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: 07/06/2021

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