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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem Loss of consciousness (2418)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6), the freedom driver exhibited a fault alarm for a few seconds and then the driver stopped.Patient's husband switched the patient to the back-up freedom driver and during this time the patient was unconscious and/or without support for approximately 90 seconds.The customer also reported while on the phone with the patient's husband, the patient regained consciousness, awake, alert, and oriented to person, place, and time (aao x3).Husband stated patient was at her baseline and also had not experienced any issues prior to event.Due to severity, husband called 911 and the patient was transported to (b)(6).Upon arrival at (b)(6) ed, patient was at baseline without complaints.New freedom driver functioning appropriately with slight low fill volume (fv) in mid 40s and cardiac output (co) in the mid 5 range.Patient was assessed with no findings and was discharged on (b)(6) 2021.

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that on (b)(6) 2021, the freedom driver exhibited a fault alarm for a few seconds and then the driver stopped.Patient's husband switched the patient to the back-up freedom driver and during this time the patient was unconscious and/or without support for approximately 90 seconds.The customer also reported while on the phone with the patient's husband, the patient regained consciousness, awake, alert, and oriented to person, place, and time (aao x3).Husband stated patient was at her baseline and also had not experienced any issues prior to event.Due to severity, husband called 911 and the patient was transported to (b)(6).Upon arrival at (b)(6) ed, patient was at baseline without complaints.New freedom driver functioning appropriately with slight low fill volume (fv) in mid 40s and cardiac output (co) in the mid 5 range.Patient was assessed with no findings and was discharged on (b)(6) 2021.

Manufacturer Narrative

An internal visual inspection of the driver revealed dark debris surrounding the primary motor.Upon further inspection, the primary motor revealed dark stains and dark debris on the cam follower plate surface.Dark debris could also be found on the primary motor side of the scotch yolk.Additionally, the cam follower of the secondary motor was misaligned and the scotch yolk had a visible crack.The exact source of the debris could not be conclusively determined.The root cause of the customer-reported fault alarm and driver stop was accumulated debris which caused the primary motor to bind up, leading to the secondary motor operation and annunciated alarm as designed.The secondary system was most likely unable to operate due to interference with the primary motor through the scotch yoke.Syncardia has opened a corrective and preventive action (capa-2022-0027: corporate-freedom driver primary motor and piston cylinder assembly failure) for this issue.Syncardia has completed its investigation and is closing this file.(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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 13018949
• MDR Text Key: 285153233
• Report Number: 3003761017-2021-00234
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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 Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female