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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 07/16/2022

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

The customer, a syncardia authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting a patient after a short cough.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Driver passed incoming functional testing.Visual inspection of external components found no evidence of damage or abnormalities.Visual inspection of internal components found the secondary motor out of the default position.Review of alarm history data found three alarms recorded in the driver's eeprom.The first two alarms were confirmed to have been produced at syncardia during functional test during the last service interval.The third alarm, can occur as a result of secondary motor engagement.Additional testing was performed at both normotensive and hypertensive setting in order to replicate the customer reported fault alarm.During the testing, the driver operated as intended.No permanent alarms occurred; no device malfunction was identified.The investigation was able to confirm the customer reported fault alarm through visual inspection and alarm history review.Inspection of internal components found the secondary motor out of the default position and a fault alarm was recorded in the alarm history.Both of these events are indicative of secondary motor engagement.When the secondary motor engages, the driver goes into permanent fault alarm requiring the driver to be removed from the patient.The driver is designed to switch to secondary motor operation but it is not intended to provide ongoing patient support while operating on the secondary motor.Operation switch from primary to secondary motor is not a device malfunction.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: 15218390
• MDR Text Key: 298291022
• Report Number: 3003761017-2022-00070
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• 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 Age: 44 YR
• Patient Sex: Male