It was reported that a peritoneal dialysis (pd) patient is currently in the hospital for a yeast infection.As a result, the pd catheter (not a fresenius product) was removed.Upon follow up, the patient's pd nurse reported that the patient was hospitalized with symptoms of abdominal pain.It was reported the patient had a pd catheter exit site infection and peritonitis.Per the nurse, the patient's pd culture (date unknown) grew yeast.Reportedly, during hospitalization the patient was treated with unspecified antibiotics.Additionally, the patient underwent removal of the pd catheter and was transferred to hemodialysis.The patient was discharged on an unknown date is reportedly recovering from the event.There were no reported fluid leaks in relation to the event.Moreover, the pd nurse indicated the peritonitis is not related in any way to fresenius device, or product.Per the nurse, the patient has a history of being non-compliant with infection control and reportedly does not wash the pd catheter exit site or wash hands during the pd exchange.The nurse attributed the peritonitis event to a breach in aseptic technique and from the exit site infection of the pd catheter.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
|