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

Catalog Number 595000-001

Device Problems Appropriate Term/Code Not Available (3191); Audible Prompt/Feedback Problem (4020)

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

Event Date 12/19/2022

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 freedom driver #5291 went into red and irreversible alarm immediately without any reason.

Manufacturer Narrative

Alarm history and patient data file review found no new alarms recorded in the freedom driver's data file.Visual inspection of internal and external components revealed no damage or abnormalities.Freedom driver passed all incoming functional testing.Additional functional testing included a power cycle test, where left and right batteries are alternately replaced 10 times each.No alarms were produced during this test.Testing was not able to replicate the condition, no fault alarms occurred during this test.The driver's power adaptor and/or freedom batteries in use at the moment of the reported issue were not returned with the driver therefore; not included in the investigation.Failure investigation for this complaint could not confirm the reported issue via alarm history data review nor functional testing.The complaint was not replicated via functional testing.The root cause of the customer reported alarm was unable to be determined.Failure investigation identified no test failure, damage or abnormalities that could have contributed to the reported alarm.Driver functioned as intended.Patient was switched to back-up driver without any reported adverse impact.This issue will be monitored 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: 16137992
• MDR Text Key: 308374304
• Report Number: 3003761017-2022-00154
• 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: 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: 01/11/2023
• 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: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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