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

Device Problem Material Twisted/Bent (2981)

Patient Problems Abdominal Pain (1685); Pneumonia (2011); Abdominal Cramps (2543); Cough (4457)

Event Type  Injury  

Event Description

On (b)(6) 2022 fresenius became aware this patient with end stage renal disease (esrd) on continuous cyclic.Peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized for a week due to drain abdominal pain, cramping, and a continuous cough.Follow-up with the patient's pd registered nurse (pdrn) confirmed the patient was hospitalized on (b)(6) 2022 due to abdominal pain, cramping, and severe cough.The patient was diagnosed with community acquired pneumonia (characterized by the cough), as well as a malfunctioning pd catheter (not a fresenius product).The pd catheter reportedly became intertwined with the patient's bowel, which was the source of the patient's drain complications, abdominal pain, and cramping.While hospitalized (prior to surgery) the patient requested to be transitioned to hemodialysis (hd), as the patient felt pd therapy was not a good fit.Therefore, the patient's pd catheter was surgically removed, and a permanent hd catheter (not a fresenius product) was placed.The patient underwent several hd treatments while hospitalized without issue and was discharged on (b)(6) 2022 in stable condition.The patient is recovering from the events and began outpatient hd therapy on (b)(6) 2022 without issue.Per the pdrn, the events were unrelated to the patient's utilization of any fresenius product(s) and/or device(s).(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: 17488355
• MDR Text Key: 320687325
• Report Number: MW5121054
• 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: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1