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

Catalog Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

The customer, a syncardia authorized distributor, reported the patient experienced a red alarm after a lightning strike near his home.

Manufacturer Narrative

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

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two new alarms for speaker 2 voltage being too low when off and for left drive pressure being too low for long enough to cause a permanent time-out.Alarms were likely produced due to intermittent communication errors and as a result of the driver running while disconnected from the patient, respectively.Visual inspection of external and internal components found no abnormalities.Freedom driver passed all functional testing for acceptance at incoming inspection.Additional testing was performed to rule out intermittent connection errors with the onboard battery power supply.Power cycling and interchanging the batteries did not result in a malfunction or alarm.Complaint could not be replicated.Failure investigation for this complaint confirmed the reported issue.The specific customer complaint could not be replicated; root cause of the alarm was unable to be determined but was likely due to a power surge from the nearby lightning strike.Sudden fluctuations in voltage can cause alarms on the freedom driver to trigger and lightning is a known cause.Failure investigation found no test failures or damage that could have contributed to the complaint.Freedom driver functioned as designed.Patient was switched to backup driver without any 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.

Event Description

The customer, a syncardia authorized distributor, reported the patient experienced a red alarm after a lightning strike near his home.

• 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: 17408393
• MDR Text Key: 320154014
• Report Number: 3003761017-2023-00108
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• 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: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2018
• 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
• Patient Age: 62 YR
• Patient Sex: Male