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

Catalog Number 595000-001

Device Problem Mechanical Problem (1384)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

During routing evaluation, a syncardia service technician reported that the driver failed incoming testing for high left driveline peak pressure.

Manufacturer Narrative

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

Manufacturer Narrative

Alarm history and patient data file review found three new alarms recorded in the freedom driver's eeprom, all 2d fault code alarms which were recorded during eeprom extraction.Visual inspection of internal and external components revealed no abnormalities.During the investigation, the freedom driver failed incoming functional testing for high left driveline peak pressure.Because this type of failure is produced by a defective piston cylinder assembly, a known good piston cylinder assembly was installed in the freedom driver.A functional test was reperformed and the driver passed all sections of the test under these conditions.The failure was replicated during the investigation via functional testing.The root cause of the failed testing is a faulty piston cylinder assembly.Failure occurred during routine service, therefore no impact to patient.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.).(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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16561060
• MDR Text Key: 311661191
• Report Number: 3003761017-2023-00030
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2017
• 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