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

Catalog Number 595000-001

Device Problems Output Problem (3005); Insufficient Information (3190)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

Freedom driver (b)(6) failed functional testing at incoming inspection for out of specification flow meter value and driver display value allowable difference range.

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 no new alarms.Visual inspection of external components found a broken seven pin connector on the external power to main pcba cable.Visual inspection of internal components found the left anchor boss for the main pcba on front housing broken as well as the primary motor's inability to spin freely when manually rotated.Freedom driver failed functional testing for acceptance at incoming inspection due to out of specification cardiac output.Additional testing included tightening the nylon barb fittings on the driver's air flow bypass as it was confirmed to be loose.As this is a common root of the reported issue, functional testing was repeated after addressing the loose fittings.Driver passed all areas of functional testing without issue.Failure investigation for this complaint confirmed the reported issue through functional testing.The customer complaint was replicated; the root cause of the out of specification cardiac output was determined to be due to loose nylon barb fittings affixed to the air flow bypass connector.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Damage to internal and external components were cosmetic only.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.If new or additional information is received in the future, syncardia will file a follow-up mdr.

Event Description

Freedom driver #5100 failed functional testing at incoming inspection for out of specification flow meter value and driver display value allowable difference range.

• 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: 18097545
• MDR Text Key: 328624761
• Report Number: 3003761017-2023-00156
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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 Operator: Other
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 04/30/2024
• 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