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

Catalog Number RTLR180111

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

Patient Problem Myocardial Infarction (1969)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a clinical investigation was performed to identify a causal relationship between the peritoneal dialysis (pd) treatment and the adverse event.Based on the provided information there is no documentation to show a causal relationship between the patient¿s myocardial infarction and subsequent hospitalization and the liberty cycler.Additionally, there is no report of a device malfunction against the liberty cycler for this event.It cannot be determined if there is a temporal relationship between pd therapy on the cycler and the myocardial infarction as there is no documentation to show if the patient was in active treatment at the time of the event.It is probable that the patient¿s extensive history of cardiac comorbidities contributed to the event.Plant investigation: the reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no nonconformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.

Event Description

A follow up call with a peritoneal dialysis (pd) patient¿s nurse on an unrelated event revealed the patient was hospitalized on (b)(6) 2018 for a myocardial infarction (mi).It was unknown what signs and symptoms the patient experienced.On unknown date during the hospitalization the patient had stents placed.The rest of the hospital course is unknown.It is unknown if the patient continued peritoneal dialysis therapy during the hospitalization.The patient has an extensive history of unspecified cardiac issues.It is unknown if the patient was actively dialyzing at the time of the event.

• Brand Name: LIBERTY CYCLER ASSEMBLY
• 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: 7347104
• MDR Text Key: 102706251
• Report Number: 2937457-2018-00803
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2011
• 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
• Patient Outcome(s): Hospitalization; Required Intervention