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

Model Number 595000-001

Device Problem Output Problem (3005)

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

Event Date 10/06/2021

Event Type  malfunction  

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.

Manufacturer Narrative

The freedom driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.

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 no new alarms.Visual inspection of external components found display cover was cracked.Visual inspection of internal components found no abnormalities.Freedom driver failed functional testing for out of specification left atrial pressure and cardiac output.Additional testing included retesting the driver with a known functional replacement piston cylinder assembly.Driver passed all areas of functional testing with replacement pca.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during functional testing; root cause of out of specification lap and co was determined to be a faulty piston cylinder assembly.Failure investigation identified no other test failures or damage that could have contributed to reported complaint.Damage to display cover was cosmetic only.Device was not in patient use at time of complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

• 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: 12635489
• MDR Text Key: 281416527
• Report Number: 3003761017-2021-00202
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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