MAUDE Adverse Event Report: SYNCARDIA SYSTEMS INC. SYNCARDIA FREEDOM DRIVER; SYNCARDIA FREEDOM DRIVER TOTAL ARTIFICIAL HEART

Model Number 595000-001

Device Problems Device Alarm System (1012); Failure to Pump (1502); Failure to Sense (1559)

Patient Problems Cardiac Arrest (1762); Seizures (2063); Respiratory Failure (2484)

Event Date 07/11/2016

Event Type  Injury  

Event Description

Pt (b)(6) - on (b)(6) 2016 patient seen in outpatient clinic stable no issues.At about 10:15 pm, patient reports "suddenly felt different." described hearing his driver sound different and hearing his pump stop.He was able to call out to his wife.Wife noted plugged in lights on.Patient became unresponsive/seized.No audible alarms.Wife was able to exchange driver and began mouth to mouth.Pt responded, ems brought him to our ed via helicopter.Ems called (b)(6) on.Call staff when arrived at patient's home.Pt admitted to (b)(6) hospital, was switched in ed to (b)(6) stock freedom driver.In am he was switched to his original back-up driver - (now primary) and supplied a back up driver.While hospitalized, labs completed and patient monitored discharged to home (b)(6) 2016 evening.No harm noted to patient.Equipment shipped to syncardia 07/12/2016.Ongoing investigation of equipment by manufacturer with weekly conference calls and update awaiting manufacturer.Summary of investigation.(b)(4) now primary.(b)(4) back-up.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: SYNCARDIA FREEDOM DRIVER TOTAL ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS INC.; 1992 e. silverlake rd.; tucson AZ 85713
• MDR Report Key: 5829658
• MDR Text Key: 50729042
• Report Number: 5829658
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2016
• Distributor Facility Aware Date: 07/11/2016
• Event Location: Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 88