MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER ASSY; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER

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

Patient Problem Chest Pain (1776)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis (pd) patient reported that the cycler was alarming for ¿supply bag lines are blocked¿ while in dwell 2 of 3, even after rebooting the cycler.The patient was able to complete treatment using continuous ambulatory peritoneal dialysis (capd), however, the patient¿s chest was hurting and felt heavy.The pd nurse reported that the patient presented to the clinic the following day ((b)(6) 2018).The patient had a little fluid retention and was instructed to use more 2.5% solution.The patient¿s blood pressure and heart rate were normal.The patient was reportedly overwhelmed with the new transition to the cycler machine.The pd nurse stated that the cause of the chest pain was from possible anxiety as the patient started pd therapy on the cycler in (b)(6) 2017.Prior to pd treatment on the cycler, the patient had been doing manual exchanges for three months.The pd nurse stated that the patient¿s chest pain had resolved and was not administered any medication for the chest pain.The patient did not miss any pd treatments.The patient continues pd therapy on the cycler.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances or any associated rework during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: LIBERTY CYCLER ASSY
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7224151
• MDR Text Key: 98411433
• Report Number: 2937457-2018-00279
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 02/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180020
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/29/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PERITONEAL DIALYSIS (PD) FLUID; LIBERTY CYCLER SET; PERITONEAL DIALYSIS (PD) FLUID
• Patient Outcome(s): Other
• Patient Age: 78 YR