MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 595000-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/17/2018

Event Type  Death  

Manufacturer Narrative

At this time, it is unknown if the patient's tah-t was explanted.The location of the patient's freedom driver system equipment is also unknown at this time.An investigation will be conducted by syncardia when the freedom driver system is located and returned.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

On 20jun2018, syncardia managing director received a phone call from the customer reporting that patient (b)(6) was found deceased at his home on (b)(6) 2018.The following information was relayed to the customer by the patient's brother.The brother reported that the patient lived alone, however, every day the patient's brother looked in on him and may have seen the patient that morning.The brother called in the evening but the patient did not answer the phone (brother thought he went to bed early).When the brother could not reach the patient the next day, he called the police and they found the patient deceased in the bathroom on the floor.The customer also reported that the police have not contacted the hospital.The location of the patient's freedom driver system equipment is unknown.The patient's body was taken to (b)(6) for autopsy.

Manufacturer Narrative

A meeting was held on 08-nov-2018 at (b)(6) germany to conduct a field performance evaluation of freedom driver s/n (b)(4) and system accessories.Mr.(b)(6), expert for medical technology, from tuv sud was in attendance.Mr.(b)(6) delivered the equipment to (b)(4).The items delivered are listed below: freedom driver s/n (b)(4).Freedom power adapter s/n (b)(4).Freedom eu power supply s/n (b)(4).Freedom onboard batteries s/ns (b)(4).Freedom battery charger s/n (b)(4).Mr.(b)(6) explained that approximately 2 months ago (near the time he received the equipment) he charged all the batteries using the included freedom onboard battery charger.He inserted one fully charged battery (not sure which one) into the driver to test functionality.He reported hearing the driver activate upon insertion of the charged battery, and reported that the driver ran for approximately 1-2 minutes before he removed the charged battery which stopped the driver.Visual inspection of the external and internal components of the freedom driver revealed no damage or abnormalities.The alarm history (eeprom) was reviewed and revealed two alarms induced during eeprom data extraction as expected and that the remaining alarms were caused as a result of the driver being operated under battery only power to the point that both batteries were fully depleted.Eeprom review revealed no evidence the freedom driver system operated outside of its intended design.Freedom driver s/n (b)(4) was subjected to a functional testing in accordance with mfg-152, freedom driver final test and acceptance procedure and was determined to function as intended.Freedom onboard batteries s/ns (b)(4) delivered by tuv with freedom driver s/n (b)(4), were evaluated per mfg-191, freedom onboard battery evaluation procedure.They were determined to function as intended during this evaluation.The investigation concluded that the freedom driver system performed as intended and there was no evidence of a device malfunction.The explanted 70cc tah-t and freedom driver system equipment remain in the possession of tuv.If the tah-t is returned to syncardia, an explant analysis will be performed and the results will be provided in a follow-up mdr.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7767847
• MDR Text Key: 116595178
• Report Number: 3003761017-2018-00429
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/08/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR