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 Problems Chest Pain (1776); Congestive Heart Failure (1783); Myocardial Infarction (1969)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the patient was hospitalized on (b)(6) 2018 due to congestive heart failure and chest pain.The pd patient was able to continue pd treatments in the hospital using the hospital machine.Medical records were requested.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the patient was hospitalized on (b)(6) 2018 due to a myocardial infarction, congestive heart failure and chest pain.It was unknown if the patient's congestive heart failure was pre-existing or found upon hospital admission.The patient was treated with stent placement.The pd patient was able to continue pd treatments in the hospital using the hospital machine.Medical records were requested.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2018 the peritoneal dialysis registered nurse (pdrn) documented this patient had been hospitalized on (b)(6) 2018 for congestive heart failure and chest pains.Per the pdrn, the patient was completing pd therapy in the hospital utilizing the hospital machine.Additional information received on (b)(6) 2018 reported the patient was admitted to the hospital for myocardial infarction and treated with a stent replacement (unknown date).It was also unknown if the congestive heart failure was a pre-existing condition or was diagnosed while hospitalized.Other hospital course unknown.The patient was still currently hospitalized.

Manufacturer Narrative

Conclusion: based on available information it cannot be determined if there is a causal relationship between the event of chest pain, congestive heart failure and subsequent diagnosis of myocardial infarction and the liberty cycler, however, there are no allegations of a malfunction against the liberty cycler or any fresenius products related to this event.Additionally, it is unknown if the patient was completing ccpd treatments on the cycler prior to the hospitalization and there is no documentation to show a causal relationship.Furthermore, the patient had a stent placement due to the myocardial infarction which suggests a pre-existing cardiac issue.Patients with esrd are at increased risk for cardiac events including acute myocardial infarction.A supplemental medwatch report will be submitted upon completion of the investigation.

Manufacturer Narrative

Plant investigation: 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

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2018 the peritoneal dialysis registered nurse (pdrn) documented this patient had been hospitalized on (b)(6) 2018 for congestive heart failure and chest pains.Per the pdrn, the patient was completing pd therapy in the hospital utilizing the hospital machine.Additional information received on 02/02/2018 reported the patient was admitted to the hospital for myocardial infarction and treated with a stent replacement (unknown date).It was also unknown if the congestive heart failure was a pre-existing condition or was diagnosed while hospitalized.Other hospital course unknown.The patient was still currently hospitalized.

• 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: 7234019
• MDR Text Key: 98781817
• Report Number: 2937457-2018-00329
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/08/2018

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 Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/01/2018
• Supplement Dates Manufacturer Received: 02/02/2018; 02/08/2018; 03/08/2018
• Supplement Dates FDA Received: 02/02/2018; 02/08/2018; 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER CASSETTE; PD SOLUTION; LIBERTY CYCLER CASSETTE; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR