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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Type  Injury  

Event Description

It was reported to fresenius that a peritoneal dialysis (pd) patient on continuous cyclic pd (ccpd) therapy on the liberty select cycler experienced peritonitis.In the initial reporting, there was no specific allegation that the adverse event was due to a deficiency or malfunction of any fresenius product or device.Upon follow-up, the patient's pd registered nurse (porn) reported the patient presented to the outpatient clinic with symptoms of abdominal pain and cloudy peritoneal effluent fluid.The patient was prescribed antibiotics (unknown type, route, dose and frequency) prophylactically prior to laboratory testing or clinical evaluation.The following day, the patient reported to the emergency department with worsening symptoms.Peritoneal effluent fluid cultures taken in the emergency department presented no growth and a white blood cell (wbc) count of 37 /mm3.The patient was diagnosed with spontaneous bacterial peritonitis due to unknown etiology and admitted to the hospital on the same day.The patient was prescribed intraperitoneal ceftazidime at 1000 mg every day for two weeks and, due to the severity of the infection, the patient's pd catheter (not a fresenius product) was removed.A tunnel catheter was placed in favor of hemodialysis (hd) on a hospital provided hd machine (unknown brand and model) during the admission and the patient was prescribed intravenous gentamycin following every hd treatment for 9 doses (unknown dosage).The patient has recovered from the event and was discharged ten days later.It was the contention of the patient's porn that the event was due to "user error", but this could not be confirmed through medical records in the outpatient clinic.However, it was reported the patient's peritonitis and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continued hd for renal replacement therapy on an outpatient basis post-discharge.The patient resumed continuous cyclic pd therapy on the liberty select cycler at home in (b)(6) 2020.(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: 17536002
• MDR Text Key: 321161224
• Report Number: MW5142894
• 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: 11/27/2020

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