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

Catalog Number P/N 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated at syncardia.The results will be provided in a follow-up mdr.

Event Description

During routine evaluation, a syncardia service technician reported that the freedom driver failed incoming testing.The driver alarmed when powered and neither motor engaged.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two new alarms, system current too high and secondary motor voltage too high.Fault codes indicated primary motor could not engage, confirming customer complaint.Visual inspection of external components found no abnormalities.Visual inspection of internal components found secondary motor out of primary alignment, indicating attempted secondary motor engagement, further confirming customer complaint.Freedom driver failed functional testing at incoming inspection.Driver immediately alarmed when powered on with both motors unable to engage.Primary motor was also found to be seizing and could not be turned by hand.A replacement primary motor was installed.Freedom driver passed all areas of functional testing.A test of the secondary motor system was performed and driver passed all areas of functional testing without issue or alarm.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated via functional testing; root cause of the alarm and motor engagement malfunction was determined to be a faulty primary motor.Binding motors are a known issue and are currently under investigation.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Device was not in patient use at time of complaint.This issue will be monitored and trended as part of the customer complaint process.Syncarida has completed its evaluation and is closing this file.If new or additional information is received in the future, syncarida will file a follow-up mdr.

Event Description

During routine evaluation, a syncarida service technician reported that the freedom driver failed incoming testing.The driver alarmed when powered and neither motor engaged.

• 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: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16997711
• MDR Text Key: 315960028
• Report Number: 3003761017-2023-00076
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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