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

Device Problems Malposition of Device (2616); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 07/12/2021

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient was in treatment on (b)(6) 2021 when the liberty select cycler began getting noisy.The patient began to drain too fast, and experience drain pain.The porn stated the liberty select cycler did not alarm.The treatment records were reviewed by the pdrn and there were no issues with the liberty select cycler prior to the draining too fast.The patient was sent for x-rays, and it was noted that the pd catheter (not a fresenius product) was malpositioned.The patient underwent a pd catheter revision on (b)(6)2021 to correct the position.This was done in an outpatient procedure.The patient is currently completing manual exchanges and will transfer to another manufacturer's device as this is the second occurrence for the same event.The patient's spouse does not wish to utilize the liberty select cycler any further.(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, PD CATHETER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532552
• MDR Text Key: 321134972
• Report Number: MW5139460
• 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: 08/10/2021

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
• Treatment: FJS