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.

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 no new alarms recorded in the freedom driver's eeprom.Visual inspection of internal and external components revealed no abnormalities.Freedom driver failed incoming functional testing for low cardiac output values.Because low cardiac output is typically produced by a defective piston cylinder assembly, a known, viable piston cylinder assembly was substituted.Functional testing was repeated and the driver passed all sections.Failure investigation for this complaint confirmed the reported issue via functional testing.The complaint was replicated via functional testing.The root cause of the reported issue is a faulty piston cylinder assembly.Out of specification left atrial pressure readings caused by faulty piston cylinder assemblies on freedom drivers is a known issue being addressed under capa-2022-0005.Failure investigation identified no other test failure, damage or abnormalities that could have contributed to the reported issue.This complaint was initiated based on routine service and thus there is no patient involvement.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) 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: 16835062
• MDR Text Key: 314449531
• Report Number: 3003761017-2023-00057
• 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: 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