MAUDE Adverse Event Report: SYNCARDIA FREEDOM DRIVER; TOTAL ARTIFICIAL HEART SUPPORT

Model Number 5148

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Fainting (1847)

Event Date 02/23/2018

Event Type  Injury  

Event Description

My husband freedom driver that he had been on for 2 wks went into a red alarm failure.He became symptomatic with decreased fill volumes and cardiac output.Impacting breathing, speaking and he felt like he was passing out.I had to immediately change the device at home.Part of the frustration of this device only being weeks old and changed on (b)(6) was that out original scheduled appt was (b)(6) and we could not change him as both machines had very strange noises.Hospital did not feel it was safe to use either machine.The 2 bad machines were serial numbers (b)(4).When we changed him on (b)(6), the original machine went to red alarm state.We are extremely apprehensive at this point with issue with 3 new machines in less than a month.It appears the quality is degrading worse than it was and is having negative impact on my husband.I am frustrated and we are on edge over these devices.

• Brand Name: FREEDOM DRIVER
• Type of Device: TOTAL ARTIFICIAL HEART SUPPORT
• Manufacturer (Section D): SYNCARDIA
• MDR Report Key: 7302393
• MDR Text Key: 101312846
• Report Number: MW5075567
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/25/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5148
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 105