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

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) nurse stated the patient reported having a fluid leak coming from the pd catheter and the fresenius cassette connection (at the end of treatment).Per the nurse, the cycler was not involved.The nurse does not know what exactly caused this leak.The cassette has been thrown away and not available for return.(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: 17526441
• MDR Text Key: 321372893
• Report Number: MW5133380
• 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: 01/25/2022

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