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 11/01/2022

Event Type  malfunction  

Event Description

Short red alarm every hour for 2 days.Swapped driver out.The patient said that he had no changes of cardiac output or fill volumes.He was doing fine with no clinical abnormalities.

Manufacturer Narrative

Alarm history and patient data file review found 2 new alarms recorded in the driver's data file: codes 36 and 12.Alarm code 36; speaker 2 voltage too low when off, is a permanent alarm that was not reported on this complaint, therefore; it is unknown when and how this alarm was produced.This alarm is typically produced by power cycling the driver while disconnected from ac power.Alarm code 12; tdc time out.This alarm was likely produced in house while extracting driver's data file.Visual inspection of internal and external components revealed no abnormalities.Driver passed incoming functional testing.A 72-hour observation run at normotensive settings was performed in an effort to reproduce the customer reported fault alarm.No alarms were produced during this test.Failure investigation for this complaint could not confirm the reported issue via alarm history data review nor functional/observational testing.The complaint was not replicated via functional or observational testing.The root cause of the customer-reported intermittent 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 a back-up driver with no reported adverse impact.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: 15834213
• MDR Text Key: 304966908
• Report Number: 3003761017-2022-00129
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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
• Patient Age: 30 YR
• Patient Sex: Male