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

Device Problem Contamination (1120)

Patient Problems Abdominal Pain (1685); Fever (1858); Peritonitis (2252)

Event Date 08/11/2020

Event Type  Injury  

Event Description

It was reported a peritoneal dialysis (pd) patient had peritonitis.Upon follow up with the pd registered nurse (pdrn), it was reported this patient presented to the emergency department on (b)(6) 2020 with symptoms of severe abdominal pain, fever and cloudy peritoneal effluent fluid.Peritoneal effluent fluid cultures were taken in the hospital on (b)(6) 2020 yet the results were not reported to the patient's outpatient clinic.However, the hospital did report a white blood cell (wbc) resulted in a count of 1333/mm3.The patient was diagnosed with peritonitis due to touch contamination of the pd catheter (not a fresenius product) at home and was admitted to the hospital on the same day.It was reported while not connected to the liberty select cycler, the patient removed the cap to their pd catheter with bare hands to drain peritoneal effluent fluid in their garage, prior to the onset of symptoms (exact date unknown).The patient was prescribed intravenous (iv) ceftazidime every day and iv vancomycin every three days (dose and duration unknown).During this admission, the patient's pd catheter was removed in favor of hemodialysis (hd) for renal replacement therapy due to the severity of the peritonitis.The patient had an uneventful hospital course and was discharged on (b)(6) 2020.The patient has continued hd for renal replacement therapy starting on (b)(6) 2020 with no plan to resume pd currently.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530361
• MDR Text Key: 321069208
• Report Number: MW5137280
• 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: 08/28/2020

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