A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) for renal replacement therapy (rrt) since (b)(6) 2020 was experiencing "very bad" drain pain when the patient's residual peritoneal volume was approaching 500 ml.Follow-up with the patient's peritoneal dialysis registered nurse (porn) confirmed the patient underwent their third unsuccessful pd catheter (not a fresenius product) revision surgery on (b)(6) 2020.Per the porn, due to the patient's obesity their pd catheter (not a fresenius product) is becoming entangled in her bowels while prone, which is partially causing her drain pain.Additionally, the patient suffers from several undisclosed gi disorders (including irritable bowel syndrome) which are negatively impacting their ability to perform ccpd therapy pain free.The patient was transitioned to outpatient hemodialysis (hd) on (b)(6) 2020 until a plan can be formulated.The porn stated the events were unrelated to a malfunction or deficiency of any fresenius device(s) and/or product(s).The porn reported the patient's drain pain is a byproduct of her anatomy, comorbidities, and most recently her pd catheter insertion site was found to be leaking post-surgery (sutured-resolved).(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
|