MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY SELECT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Chest Pain (1776); High Blood Pressure/ Hypertension (1908)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

There is no documentation to show a causal relationship between the patient event of drain complications and subsequent chest discomfort and the liberty cycler.Additionally, there is no reported allegation of a machine malfunction for this event.It was stated that the patient had pre-existing adhesions which affected the patient¿s drains.The patient¿s chest discomfort and elevated blood pressure is attributed to the inadequate draining due to the adhesions and the history of hypertension.There is however, a temporal relationship between the patient¿s drain complications, chest discomfort and elevated bp and their ccpd therapy on the liberty select cycler.The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

During routine follow up on a separate experience the contact for this male patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) stated that the patient did not complete treatment on (b)(6) 2018.The contact reported that the patient went to the emergency room (er) for chest pain.It was also noted that the patient was scheduled for surgery (unspecified type and date) but was canceled due to the chest pain.Follow up with the patient¿s peritoneal dialysis registered nurse documented that the nephrologist sent the patient to the er for a pd catheter (not a fresenius product) evaluation.This patient has had drain complications due to previous adhesions.While at the er, the patient began to complain of chest discomfort which was attributed to inadequate draining (due to the adhesions) and elevated blood pressure (bp) (unknown values).Per the peritoneal dialysis nurse, the patient has a history of hypertension.The patient was subsequently admitted to the hospital and transitioned to temporary hemodialysis (hd) therapy.Hospital course is unknown.The patient was scheduled for a stress test and cardiac catheterization (date unknown).Additional information was solicited.

Manufacturer Narrative

Hospitalized, required intervention.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7304070
• MDR Text Key: 101199927
• Report Number: 2937457-2018-00630
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR