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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 08/11/2016

Event Type  Death  

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00321; freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00341) and; freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00342).The customer reported that, according to the patient's girlfriend, the patient and his roommate had to change out his freedom driver "multiple times" that morning.The girlfriend did not know what type of alarms nor how many times the freedom driver was exchanged, as she was not there at the time.The customer also reported that when hospital personnel spoke directly with the patient earlier in the day regarding lab results, he did not mention any freedom driver alarms or exchanges.The customer also reported that the patient was supplied with two backup freedom drivers, but was unsure which driver was supporting the patient at the beginning of the day.The customer also reported that, according to the girlfriend, who was not at the home during these events, the patient's (b)(6) son, who was not a trained caregiver, heard an alarm, then a crash.The son found his father lying on his stomach, but was unable to turn him over to check anything out.The son did not know what the alarm was and he did not know where the backup driver was located.The son called a neighbor that lived nearby for help, and then called the patient's caregiver who returned home, retrieved the backup driver and switched the patient.The customer also reported that this series of events lasted approximately 45 minutes and the patient was blue in color when the backup driver was connected and the ambulance arrived.The customer also reported that the patient was transported to a non-certified syncardia tah-t center hospital.A hospital representative reported to (b)(6) that to her knowledge, the patient arrived with a functioning driver but had expired.The hospital called the syncardia hotline because they were unfamiliar with the device and didn't know how to turn it off.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's internal and external components indicated that at least one significant impact shock had occurred to the driver.The damage indicated the following sequence of events: there was a significant impact shock to the driver that moved the secondary motor cam-follower out of bottom dead center (bdc) position.Subsequently, there was mechanical interference between the primary motor, secondary motor and scotch yoke.The scotch yoke broke which created mechanical interference and caused an over-current event.This over-current event caused damage to the main printed circuit board assembly (pcba) and led to a permanent fault alarm (as recorded in the electronic data.) based on the above sequence of events, the root cause of the alarm annunciated during functional testing was a significant impact shock to the driver.It cannot be determined with certainty whether freedom driver s/n 4826 supported the patient, but it can be determined that the driver in its "as-received" state would not be capable of performing its life-sustaining functions.Patients and caregivers are instructed in the ifu and during the hands-on training by the hospital to immediately return any equipment that has been dropped.Freedom driver system guidebook for patients and caregivers section 4 warnings - caution failure to adhere to the warnings listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.Warning states "if the freedom driver or any of the accessories are dropped, bring them to your hospital for replacement." freedom driver system guidebook for patients and caregivers section 5 precautions and recommendations - caution failure to adhere to the precautions and recommendations listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.Recommendation states "it is strongly recommended to have two people exchange the primary freedom driver for the backup freedom driver.The customer reported that the patient was left without his caregiver.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1 (2 of 3).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under three separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00321, freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00341) and freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00342).The customer reported that, according to the patient's girlfriend, the patient and his roommate (unknown if person was a trained caregiver) had to change out his freedom driver "multiple times" that morning.The girlfriend did not know what type of alarms nor how many times the freedom driver was exchanged, as she was not there at the time.The customer also reported that when hospital personnel spoke directly with the patient earlier in the day regarding lab results, he did not mention any freedom driver alarms or exchanges.The customer also reported that the patient was supplied with two backup freedom drivers, but was unsure which driver was supporting the patient at the beginning of the day.The customer also reported that, according to the girlfriend, who was not at the home during these events, the patient's (b)(6) son, who was the only person with the patient and not a trained caregiver, heard an alarm and then a noise and found the patient lying on his stomach.The son did not know what the alarm was and he did not know where the backup driver was located.The son called a neighbor that lived nearby for help, and then called the patient's caregiver who returned home, retrieved the backup driver and switched the patient.The customer also reported that this series of events lasted approximately 45 minutes before the ambulance arrived.The patient was transported to a (b)(6) hospital.A hospital representative reported to (b)(4) that to her knowledge, the patient arrived with a functioning driver but had expired.The hospital called the syncardia hotline because they were unfamiliar with the device and didn't know how to turn it off.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6007391
• MDR Text Key: 56758615
• Report Number: 3003761017-2016-00341
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 51 YR