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

Catalog Number RTLR180111

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

Patient Problem Chest Pain (1776)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient called in regarding assistance to cancel treatment in order to visit the emergency room due to experiencing chest pain.The technical support assisted the patient with the request and advised to follow up with the pd nurse.During follow up the pd nurse reported the patient was not hospitalized for the issue of chest pain and was in the emergency room for a brief period.The pd nurse stated the patient has recovered from the event of chest pain and has continued pd treatment without change.Additional information was solicited but unavailable.

Manufacturer Narrative

A clinical investigation was performed to identify a causal relationship between the peritoneal dialysis (pd) treatment and the adverse event.Based on the available information it cannot be determined if there is a causal relationship between the event of chest pain and the liberty cycler, however, there are no allegations of a malfunction against the liberty cycler or any fresenius product.Patients with end stage renal disease (esrd) are at increased risk for cardiac events.The cause of the chest pain is unknown and it is unknown if the patient has pre-existing cardiac comorbidities.The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6847524
• MDR Text Key: 85079820
• Report Number: 2937457-2017-00845
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD FLUID