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); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that on 4/apr/2022 this patient on peritoneal dialysis (pd) began prophylactic antibiotic treatment due to symptoms of abdominal pain and pd catheter exit site tenderness.Per the patient's pd nurse, the patient did not experience any adverse effects from the reported cassette leaks and the events were not related.The nurse stated the patient's symptoms were present prior to the reported issue.A pd effluent culture was obtained in the outpatient pd clinic on (b)(6) 2022 which showed the patient did not have peritonitis (no organism growth and normal white blood cell count).Additionally, the patient had a pd catheter (not a fresenius product) exit site culture which generate growth of corynebacterium (normal skin flora).As a result, the patient was initiated on prophylactic ip antibiotics with vancomycin 2000mg, tazicef 2000mg, and a 2-week course of keflex due to pd catheter exit site infection and report of abdominal pain.Per the nurse, the patient is recovering and continues pd with same cycler and fresenius cassettes without any further reported issues.C-927675, (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: 17535039
• MDR Text Key: 321049040
• Report Number: MW5141939
• 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: 04/21/2022

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