MAUDE Adverse Event Report: UNKNOWN LIBERTY SELECT CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Leak/Splash (1354); Output Problem (3005)

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

Event Type  Injury  

Event Description

A peritoneal dialysis registered nurse (porn) reported the patient presented to the emergency room with abdominal pain and cloudy effluent fluid on (b)(6)2022.A peritoneal effluent fluid culture and cell count (result not provided) was collected, and the patient was admitted with peritonitis.The patient's peritoneal effluent culture returned positive for aerococcus urinae, and the patient's pd catheter (not a fresenius product) was surgically removed (reportedly also infected).The patient received a tunneled hemodialysis (hd) catheter while hospitalized and was transitioned to hd therapy.The patient was treated with intravenous antibiotics; however, the drug, dose, frequency, and duration were not provided.Further discussion revealed the patient performs continuous ambulatory pd (manual) therapy and never utilized a liberty select cycler.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LIBERTY SELECT CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17534421
• MDR Text Key: 321160730
• Report Number: MW5141322
• Device Sequence Number: 1
• Product Code: FKX
• 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: 04/22/2022

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