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

Model Number LIBERTY CYCLER

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

Patient Problem Myocardial Infarction (1969)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient was hospitalized (b)(6) 2017 due to experiencing a myocardial infarction.

Manufacturer Narrative

Consumer selected.

Event Description

A peritoneal dialysis patient was hospitalized (b)(6) 2017 - (b)(6) 2017 due to experiencing a myocardial infarction.Upon follow up with the patient's nurse, it was confirmed that the patient was admitted tot the hospital due to a heart attack and was discharged on (b)(6) 2017.The nurse was not aware of the cause and treatment.Provided dob (b)(6) 1945 and has been on pd since (b)(6) 2016.

Manufacturer Narrative

Clinical evaluation: the file has been assessed for the necessity of the performance of a clinical investigation.On (b)(6) 2017 this (b)(6) year old pt.On continuous cycling peritoneal dialysis (ccpd) (since (b)(6) 2016) was admitted to the hospital for myocardial infarction (mi) of unknown etiology.Details leading up to and surrounding the pt¿s mi event are unknown.Hospital details are also unknown however the pt.Reported receiving manual pd therapy while hospitalized.The pt.Was discharged (b)(6) 2017 continuing ccpd therapy.The pt¿s pd nurse stated hospital records would not available due to hipaa.There is no reported allegation or documentation that indicates the liberty cycler caused or contributed to the pt¿s mi event.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available please re-submit for a clinical investigation review and the need for a clinical investigation will be re-evaluated accordingly.

Event Description

A peritoneal dialysis patient was hospitalized (b)(6) 2017 - (b)(6) 2017 due to experiencing a myocardial infarction.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7173855
• MDR Text Key: 96697531
• Report Number: 2937457-2018-00095
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• 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: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD FLUID
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR