MAUDE Adverse Event Report: SYNCARDIA SYNCARDIA; FREEDOM DRIVER

Device Problems Low Audible Alarm (1016); No Display/Image (1183); Pumping Stopped (1503)

Patient Problems Death (1802); Edema (1820)

Event Date 10/02/2016

Event Type  Death  

Event Description

On (b)(6) 2016 at approximately 02:15am while at home, the patient had an unexplained fault alarm on his syncardia freedom driver that resulted in total artificial heart (tah) pump stoppage.This ultimately resulted in diffuse cerebral edema and brain stem compression, tah support was stopped at 15:59 pm on (b)(6) 2016 patient's wife called from home via the mcs emergency pager system and was connected directly to my cell.She was in distress and yelled "(b)(6), he's not alive".I was able to hear an audible fault alarm in the background.When i asked her to explain, she stated that she heard the freedom driver go into a fault alarm and ran into the bedroom where she found the patient in bed, unresponsive, with eyes open.At this time she paged me.I instructed her to check the device and see if it was actually still pumping.She stated that the device was not pumping and the display screen was blank.I was also able to hear over the phone that the pump was not pumping.I instructed and talked her through switching patient to his back-up driver.Once he was switched the freedom driver readings displayed: br 130, fv 59, co 7.5 with no alarms.The patient was still unresponsive and the patient's wife called 911, patient assessed and intubated by paramedics.Upon arrival to the local er ((b)(6) hospital), the physician confirmed that the patient remained unresponsive, without gag reflex and with dilated and fixed pupils.Patient was then emergently transferred to (b)(6) medical center, where a head ct confirmed: diffuse cerebral edema, cortical sulcal effacement, and posterior fossa herniation with compression of the brainstem.After a family meeting with the patient's wife, the tah was turned off at 15:59 on (b)(6) 2016.

• Brand Name: SYNCARDIA
• Type of Device: FREEDOM DRIVER
• Manufacturer (Section D): SYNCARDIA; tucson AZ
• MDR Report Key: 6010555
• MDR Text Key: 56830760
• Report Number: 6010555
• 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: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2016
• Distributor Facility Aware Date: 10/02/2016
• Event Location: Home
• Date Report to Manufacturer: 10/04/2016
• 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): Death
• Patient Age: 57 YR
• Patient Weight: 90