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

Catalog Number P/N 595000-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia certified hospital, reported the driver was being tested on the patient simulator and the driver was making "a straining galloping sound".

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 indicating secondary motor voltage too high.Alarms were likely produced in-house during data extraction as there was no evidence of secondary motor engagement.Visual inspection of external components found damaged display cover and fan cover.Visual inspection of internal components found the ribbon cable, speaker to lcd, has a scuff/burn mark.Freedom driver failed functional testing at incoming inspection due to out of specification cardiac output.This was unrelated to customer complaint and could not have contributed to reported issue.An additional 48-hour observation run was performed on the driver, no "galloping" or abnormal sound was produced.Customer complaint could not be replicated.The unrelated cardiac output issue was also investigated and after adjusting the barb fittings the driver was re-assessed.Driver passed all areas of functional testing after the adjustment.Failure investigation could not confirm the reported issue.The specific customer complaint could not be replicated; root cause was unable to be determined.Failure investigation identified no test failure or damage that could have contributed to the complaint.Damage found to the display cover, fan cover, and ribbon cable are cosmetic due to normal wear and tear.Unrelated cardiac output issue was determined to be caused by loose barb fittings.Freedom driver otherwise functioned as designed.Device was not in patient use at time of complaint.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.

Event Description

The customer, a syncardia certified hospital, reported the driver was being tested on the patient simulator and the driver was making "a straining galloping sound".

• 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: 17005581
• MDR Text Key: 316283116
• Report Number: 3003761017-2023-00081
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• 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