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

Catalog Number 595000-001

Device Problems Fracture (1260); Contamination /Decontamination Problem (2895); Scratched Material (3020); No Apparent Adverse Event (3189); Physical Resistance/Sticking (4012); Audible Prompt/Feedback Problem (4020)

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

Event Date 07/27/2022

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 authorized distributor, reported that the freedom driver exhibited a fault alarm while supporting a patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Incoming functional testing was performed and, upon startup, the driver emitted a grinding noise followed by secondary motor engagement and a permanent fault alarm.This confirmed the customer reported issued.Alarm history data review found two permanent alarms recorded; these occurs when the primary motor does not engage after more than five seconds and when the driver switches operation to the secondary motor.Visual inspection of exterior components found scratches on the face of both the front and rear driver housings, cracked display cover and product labeling partially illegible.Visual inspection of internal components found black, powdery debris across the top of the motor gearbox assembly, pca, fan cover and exhaust fan; the secondary motor out of default position, burn marks on the ribbon cable, which connects the speaker pcba to the lcd; small abrasions on the main pcba and the primary motor was difficult to move.The customer reported fault alarm was confirmed and replicated during incoming functional testing when the driver made a grinding noise, switched operation to the secondary motor and annunciated an alarm.The root cause of the customer reported issue is a faulty primary motor, which seized and caused the secondary motor to activate, creating a permanent fault alarm.Syncardia has a corrective and preventive action (capa) for the issue of freedom driver primary motor and piston cylinder assembly.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.(b)(4).Follow-up report 1.

• 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: 15255163
• MDR Text Key: 298290743
• Report Number: 3003761017-2022-00083
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• 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: 58 YR
• Patient Sex: Male