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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem Loss of consciousness (2418)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient awoke to the freedom driver exhibiting a fault alarm at 03:30 am.The husband reported that there were no kinks in the drivelines and no loss of power from the freedom driver.The patient did lose consciousness but regained consciousness within 30 seconds after she was switched to the backup freedom driver.The customer also reported that the patient was subsequently transported by ambulance to the hospital er and was discharged home at approximately 07:00 am.

Event Description

Hospital staff put two fully charged freedom onboard batteries in the freedom driver and there was an immediate fault alarm with no sound coming from the compressor and no air coming out the drivelines.

Manufacturer Narrative

Initial visual inspection of the driver revealed no anomalies.The driver's alarm history was reviewed and revealed four recorded alarms.The first alarm was confirmed to have been recorded during functional testing performed during service prior to shipment to the customer.The next three alarms were most likely experienced by the customer thus confirming the reported driver fault alarm condition.Initial functional testing of the freedom driver also confirmed the customer-reported issue of the driver not working, as upon startup, the driver alarmed and did not pump.Bench testing was performed to evaluate motor performance.The primary motor engaged for a few seconds then stopped and the driver alarmed.The secondary motor failed to engage.Additional bench testing was performed on each motor separately.The primary motor operated for a few seconds with an observed increase in operational noise before stopping.The secondary motor would only operate with manual rotation while power was applied and became hot after a few seconds of operation.The motors were sent to the supplier for additional testing.The results of their investigation determined that the likely root cause of the primary motor failure was two-fold; a change in motor properties over time and gearbox wear with the main contributors being external debris and internal debris causing the motor to seize.Investigation for the secondary motor failure determined that the likely root cause was the gearbox rubbing on the scotch yoke, which caused the motor drive to deliver too high of a current which in turn heated the stator and damaged the stator magnet wire insulation causing a short in the windings.The motors were returned and further evaluation at syncardia confirmed, as stated by the supplier, the external and internal debris was the primary cause of failure in the primary motor; i.E., the primary motor gearbox was so permeated with debris that the gears seized and the sun gear was damaged making it very difficult to turn.While the secondary motor did not have debris, it was most likely unable to operate due to interference with the primary motor through the scotch yoke, i.E., the torque from the secondary motor was insufficient to overcome the seized primary motor.Under this scenario, it is possible that the increase in current draw led to internal damage and the changes in properties of the motor as stated by the supplier.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(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
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11832400
• MDR Text Key: 250878665
• Report Number: 3003761017-2021-00082
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female