MAUDE Adverse Event Report: UNKNOWN LIBERTY SELECT CYCLER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Device Problem Leak/Splash (1354)

Patient Problems Ischemia (1942); Burning Sensation (2146); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The fistula used by the patient is not a fresenius device.The manufacturer of the fistula, and further product information, is unknown.(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: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17536137
• MDR Text Key: 321154297
• Report Number: MW5143027
• Device Sequence Number: 1
• Product Code: MPB
• 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: 04/26/2022

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