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

Device Problems Improper Flow or Infusion (2954); Failure to Clean Adequately (4048)

Patient Problems Peritonitis (2252); Reaction to Medicinal Component of Device (4574)

Event Date 03/28/2021

Event Type  Injury  

Event Description

The peritoneal dialysis registered nurse (pdrn) reported 76-year-old male pd patient who was hospitalized for peritonitis on (b)(6) 2021 following symptoms of abdominal pain and a blocked pd catheter (not a fresenius product).The patient's peritoneal effluent fluid cultures were taken in the hospital and presented with candida (species unknown) and an elevated white blood cell count (exact amount unknown).The porn stated the patient was diagnosed with peritonitis due to lack aseptic technique involving "unhealthy living conditions" during continuous cyclic pd (ccpd) therapy on the liberty select cycler at home.The porn reported the patient was prescribed antifungal medication and antibiotics (unknown types, route, dosages, frequencies and durations) during this hospital admission.The porn reported the patient had their pd catheter removed due to fungal growth on the interior of their pd catheter.The porn stated the patient underwent hemodialysis (hd) through an existing fistula on a hospital provided hd machine (unknown brand and model) during this admission.The porn reported the patient is recovering from this event while awaiting discharge.The porn confirmed the patient's peritonitis and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device(s) or drug(s).The porn stated the patient plans to undergo hd therapy on an in-center basis upon discharge with no plan to return to pd therapy.(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: 17531308
• MDR Text Key: 321137914
• Report Number: MW5138223
• 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: 04/16/2021

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
• Patient Age: 76 YR