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 03/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer, a syncardia authorize distributor, reported that while the patient was at home, they had multiple red alarms for two days.The fv (fill volume) and co (cardiac output) dropped and returned to normal in a second, which caused alarms.

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 one new alarm, indicating secondary motor voltage too high.As there was no evidence of secondary motor engagement, this was likely produced in-house during data file extraction.Visual inspection of external components found damage to the display and fan covers.Visual inspection of internal components found damage to the edge of the front housing.Freedom driver passed all functional testing for acceptance at incoming inspection.An additional 48-hour observation run was performed.No alarms produced and no abnormalities observed.Complaint could not be replicated.Failure investigation for this complaint could not confirm the reported issue.The customer complaint was not replicated during testing; the root cause of the alarms for temporary drops in fill volume and cardiac output could not be determined.Failure investigation identified no test failures or damage that could have contributed to the reported complaint.Damage found to the display and fan covers as well as to the edge of the front housing was cosmetic only.Freedom driver functioned as designed and no evidence of a device malfunction was found.Patient was switched to a 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 authorize distributor, reported that while the patient was at home, they had multiple red alarms for two days.The fv (fill volume) and co (cardiac output) dropped and returned to normal in a second, which caused alarms.

• 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: 16743364
• MDR Text Key: 313326353
• Report Number: 3003761017-2023-00051
• 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: 12/06/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2018
• 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: 50 YR
• Patient Sex: Male