MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS 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); Peritonitis (2252)

Event Type  Injury  

Event Description

It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) had an infection.No additional information provided during intake.Follow-up with the patient's pd registered nurse (porn) revealed while vacationing, the patient experienced a touch contamination event.The patient reported they inadvertently dropped the 'uncapped' pd catheter (not a fresenius product) and caught it in an 'ungloved' hand.The patient did not bring an antibiotic rescue kit, and therefore called their porn on (b)(6) 2021 for assistance.The patient was sent to the emergency room (er) with abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc = 365 u/l) were collected, and the patient was diagnosed with peritonitis.The patient was started on intraperitoneal (ip) yancomycin 1000 mg every other day for 21 days and ip ceftazidime i 000 mg daily for 21 days.By (b)(6) 2021 the patient's abdominal pain had subsided, and the patient was discharged home in stable condition.On (b)(6) 2021 the peritoneal effluent fluid culture results returned positive for staphylococcus epidermis, and the patient's ceftazidime was discontinued.The porn stated there was no defect or malfunction of a fresenius device(s), drug(s) and/or product(s) to report.The patient is recovering from the events and continues to utilize the same liberty select cycler as before.(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: 17532746
• MDR Text Key: 321162536
• Report Number: MW5139653
• 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: 08/12/2021

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