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 Problem Chest Pain (1776)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

During routine follow up on a customer experience it was reported that a peritoneal dialysis patient was hospitalized on (b)(6) 2018, due to chest pain.Follow up with the peritoneal dialysis nurse indicates that the cause of the patient¿s chest pain is unknown and that it is unlikely related to the patient's dialysis treatments.It is unknown if the patient was performing peritoneal dialysis treatments when the chest pain was experienced.The patient was discharged from the hospital on (b)(6) 2018 and continues with continuous cyclic peritoneal dialysis (ccpd) without any reported issues.Additional information was solicited.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between the liberty select cycler and the pt¿s chest pain which warranted hospitalization.However, there is no evidence that supports a causal relationship.Due to insufficient information, the etiology for the pt¿s chest pain is unknown.Should additional information become available, this clinical investigation will be updated accordingly.A supplemental mdr will be submitted upon device evaluation.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.Upon internal inspection, there was no presence of visible liquid or evidence of past fluid within cycler.A simulated therapy was initiated and completed on the cycler without complication.Cycler passed all function tests.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• 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: 7510311
• MDR Text Key: 108103160
• Report Number: 2937457-2018-01329
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Device Age: MO
• Date Manufacturer Received: 06/18/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 49 YR