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

Catalog Number 595000-001

Device Problems Fracture (1260); Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); No Apparent Adverse Event (3189)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

Yesterday, he had vomiting and coughing which caused red alarm, so patient decided to switch the driver.

Manufacturer Narrative

Alarm history and patient data file review found one new alarm recorded in the driver's data file, code 2d, secondary motor voltage too high, which is produced upon engagement of secondary motor.Visual inspection of internal components revealed the secondary motor's cam follower was found outside of the default bottom dead center position, two fractured housing bosses, and a fastening insert partially outside of one of the bosses.Visual inspection of external components revealed no abnormalities.Freedom driver passed all steps of incoming functional testing.A valsalva maneuver test was performed to evaluate the driver under the patient condition, vomiting, reported by the customer.An air pressure of 50 psi was applied to the pulmonary artery pressure chamber of mock tank, after approximately 2 seconds the levels in the tank were visibly disturbed and the driver exhibited a permanent fault alarm while changing the beat rate from 125bpm to 131bpm, indicating engagement of the secondary motor and and confirms the current customer complaint.The permanent alarm produced during the valsalva maneuver test was recorded in the driver's data file as a 2d code alarm.Because this was not an intended result, a second valsalva test with a test piston cylinder assembly was performed.During this test the driver performed as intended, annunciating an alarm due to low cardiac output (3.5 lpm) and recovering after a few seconds (when cardiac output increased above 3.5 lpm).Because of this, the original piston cylinder assembly was rejected and replaced.Failure investigation 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 alarm is a faulty piston cylinder assembly.Patient was switched to a back-up driver and no adverse impact was reported.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: 15979313
• MDR Text Key: 306977286
• Report Number: 3003761017-2022-00136
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Sex: Male