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

Device Problems Appropriate Term/Code Not Available (3191); Failure to Clean Adequately (4048)

Patient Problems Pain (1994); Peritonitis (2252)

Event Type  Injury  

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was reportedly hospitalized for three weeks due to an infection.The patient reported the infection in their stomach, lead to the removal of their pd catheter (not a fresenius product) and antibiotic therapy.Follow-up with the patient's pd registered nurse (porn) confirmed the patient was hospitalized on (b)(6) 2021 for abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (elevated wbc's, value unknown) was collected, and the patient was admitted for peritonitis.The patient was treated with intraperitoneal (ip) vancomycin; however, the dosage and duration are unknown.The patient's peritoneal effluent fluid culture returned positive for pseudomonas aeruginosa.The cause of which was attributed to the patient's shower head not being disinfected properly.After approximately one-week of receiving antibiotics, the patient was still experiencing abdominal pain, and the decision was made to remove the patient's pd catheter (not a fresenius product) due to the persistent infection.The patient's pd catheter was removed without issue, and a permanent hemodialysis (hd) catheter (not a fresenius product) was surgically placed.The porn stated the patient underwent several hd treatments while hospitalized without issue, and following discharge transitioned to an outpatient hd clinic on (b)(6) 2021.The patient is recovering from the events and will likely not return to pd therapy.Per the porn, the events were unrelated to the utilization of any fresenius product(s) and/or device(s).Additional information was requested (e.G., discharge summary), however the record is unable to be accessed by the home therapy department since he transferred.(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: 17530282
• MDR Text Key: 321079665
• Report Number: MW5137202
• 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: 04/07/2021

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