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

Model Number 595000-001

Device Problem Output Problem (3005)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom driver s/n 5255 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, indicating secondary motor voltage too high and bdc sensor open or short, in driver's data file.Visual inspection of external components found no abnormalities.Visual inspection of internal components found bottom right anchor boss cracked with pin-nut raised out and ribbon cable speaker to lcd display has a burn/scuff mark.Freedom driver failed functional testing at incoming inspection for out of specification left atrial pressure and cardiac output.Additionally, no red alarm occurred when drivelines were kinked.Additional testing was run with a replacement piston cylinder assembly and driver passed all areas of functional testing.Failure investigation for this complaint confirmed the reported issue.The complaint was replicated during functional and observational testing; the root cause of the out of specification lap and co was determined to be a faulty pca.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Bottom right anchor boss and ribbon cable speaker to lcd display damage was cosmetic only.Freedom driver did not function as designed.Device 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

While performing a routine evaluation, a syncardia technician reported that the freedom driver did not maintain the proper normotensive pressure values on the patient simulator.

• 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: 12635572
• MDR Text Key: 281416404
• Report Number: 3003761017-2021-00201
• 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: 11/30/2023

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: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 11/30/2023
• 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