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 05/17/2023

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 that the driver was making a scraping sound and multiple red alarms occurred.The patient was switched to a back-up driver.

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 three new alarms recorded in the driver's data file indicating secondary motor engagement and that the driver was not connected to patient for an extended period.Visual inspection of external components found no abnormalities.Visual inspection of internal components found foreign debris, dark powder, within the internal construction of the motor.A loud scraping sound occurred when the driver was powered and the primary motor was difficult to rotate manually.Freedom driver passed all functional testing for acceptance at incoming inspection.An additional observational test was performed resulting in three alarms.After 3 hours and 24 minutes, the primary motor seized up and the operation reverted to secondary motor, corroborating customer complaint.Failure investigation for this complaint confirmed the reported issue.The complaint was replicated during testing; the root cause of the fault alarm and scraping sound was the primary motor.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Patient was switched to a backup driver without any reported adverse impact.

Event Description

The customer, a (b)(6) hospital, reported that the driver was making a scraping sound and multiple red alarms occurred.The patient was switched to a back-up driver.

• 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: 17005582
• MDR Text Key: 316283128
• Report Number: 3003761017-2023-00085
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P0300111
• 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: 10/13/2023

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: 05/17/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/17/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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: 47 YR
• Patient Sex: Male