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

Catalog Number P/N 595000-001

Device Problem Mechanical Problem (1384)

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

Event Date 04/13/2023

Event Type  malfunction  

Event Description

The syncardia service technician reported that the driver failed incoming testing for low lap and low cardiac output.

Manufacturer Narrative

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

Manufacturer Narrative

Alarm history and patient data file review found two new alarms recorded in the driver's eeprom: both 2d - secondary motor voltage too high.These alarms were likely produced during eeprom data extraction.Visual inspection of internal and external components revealed no abnormalities.Freedom driver failed additional functional testing for low left atrial pressure values, thus replicating the incoming test failure reported under this complaint.As low lap is typically produced by a defective piston cylinder assembly, a conforming test piston cylinder assembly was installed in the driver.Functional testing was then repeated and the driver passed all sections.Failure investigation for this complaint confirmed the reported issue via alarm history data review and functional testing.The complaint was replicated via functional testing.The root cause of the customer reported issue is a faulty piston cylinder assembly.Failure investigation identified no other test failure, damage or abnormalities that could have contributed to the reported issue.Patient impact is not applicable.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.) (b)(4).

• 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: 16835071
• MDR Text Key: 314268597
• Report Number: 3003761017-2023-00056
• 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,Foreign
• 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: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: P/N 595000-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2023
• 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