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

Model Number 595000-001

Device Problems Activation, Positioning or Separation Problem (2906); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver exhibited a fault alarm.

Manufacturer Narrative

Alarm history and patient data file review found two new alarms recorded in the driver's eeprom: fault codes 2f and 2d.He 2f code "system current too high" is produced when the primary motor powers up but it is physically not allowed to engage , that correlates with the customer reported issue.The last fault code, 2d "secondary motor voltage too high" was produced during eeprom extraction.Visual inspection of external components revealed no abnormalities.Visual inspection of internal components revealed damage in the form of cracks with pulled out inserts on three housing anchor bosses.Secondary motor's cam follower was outside it's default bdc position.While trying to move the scotch yoke out of the way to get a picture of the secondary motor's cam follower, it was noticed that the downward movement of the yoke encountered additional unusual resistance.Further inspection of the pca revealed foreign debris inside the piston cylinder assembly, also a protruding check valve.Freedom driver passed all incoming functional testing.Attempted to duplicate the customer reported alarm by creating additional resistance to the normal operation of the driver by kinking the drivelines and/or by applying friction directly to the primary motor.Kinked the drivelines for two minutes straight, no permanent alarms were produced.Proceeded then to apply resistance by friction to the primary motor, after a few seconds the primary motor stopped, an alarm annunciated and the secondary motor engaged.A new eeprom reading confirmed the creation of a 2f alarm, thus reproducing the customer reported issue under these circumstances.Failure investigation for this complaint confirmed the reported issue via alarm history data review and observational testing.The complaint was replicated via observational testing.The root cause of the customer reported issue is non-fully seated pressure relief check valve in the piston cylinder assembly.This protruding check valve was interacting with the scotch yoke on the downward stroke, creating increased resistance / current of the primary motor and eventually causing the secondary motor to engage.(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: 11582413
• MDR Text Key: 242731896
• Report Number: 3003761017-2021-00042
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• 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?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2018
• 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