MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Date 12/04/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient had peritonitis.The patient had used a 4.25 bag and seem to start having issues and pain.The patient went to the dialysis clinic and was diagnosed with peritonitis.Upon follow up, the patient's pd registered nurse reported this patient presented to the outpatient clinic with symptoms of abdominal pain and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures taken in the outpatient clinic presented with klebsiella aerogenes and a white blood cell (wbc) count of 41,452/mm3.The patient was diagnosed with peritonitis due to touch contamination during ccpd therapy on the liberty select cycler at home.It was reported the patient disregards many aspects of aseptic technique during ccpd treatment setup.The patient was not initially hospitalized and prescribed intraperitoneal (ip) ceftazidime at 1000 mg every day for three weeks.The patient was hospitalized again and found unresolved and refractory peritonitis from (b)(6) 2020.The patient was treated with ip ceftazidime at 2000 mg with every pd treatment for no less than three weeks.There was no report of additional cultures or labs during this hospitalization as the outpatient clinic did not receive the patient's discharge paperwork.The patient's pd catheter (not a fresenius product) was removed during this admission due to the severity of the infection and a central vascular catheter was placed in favor of hemodialysis (hd) for renal replacement therapy.The patient continued hd therapy on a hospital provided hd machine (brand and model unknown) for the duration of the admission.The patient had an uneventful hospital course and was discharged on (b)(6) 2020.It was confirmed 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 is recovering from this event and continues hd therapy on an in-center basis post-discharge.The catheters used by the patient are not fresenius devices.The manufacturer of the catheters, and further product information, are unknown.(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
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17524854
• MDR Text Key: 321148557
• Report Number: MW5131797
• Device Sequence Number: 1
• Product Code: GBW
• 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: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1