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 Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969)

Event Date 11/29/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) nurse reported that a patient had a myocardial infarction and expired while on continuous cycler assisted peritoneal dialysis therapy.Additional information has been solicited.

Manufacturer Narrative

The occurrence date was updated based on medical records there is no documentation supporting a possible association between the liberty cycler and the event of cardiac arrest and the subsequent expiration of the patient.Although a temporal association between the liberty cycler and the event cardiac arrest and the subsequent expiration exist, the likely association is the patient extensive history of comorbidities including nonrheumatic valve disorder, unspecified and diabetes type 2.Additionally, the esrd death notification list the primary cause of death as cardiac arrest, cause unknown; secondary cause of death: atherosclerotic heart disease and cardiomyopathy.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-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

Event Description

The patient was disconnected from his cycler and transported to a hospital, where he was pronounced deceased.Followup with the patient's clinic director revealed no indication that the patient's pd cycler was alarming or malfunctioning on the night of the patient's passing.

• 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: 6201029
• MDR Text Key: 63170895
• Report Number: 2937457-2016-01255
• Device Sequence Number: 1
• Product Code: FKX
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2011
• 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
• Treatment: DELFLEX PD SOLUTIONS; LIBERTY CYCLER SET
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 82