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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Audible Prompt/Feedback Problem (4020)

Patient Problems Headache (1880); Loss of consciousness (2418); Lethargy (2560)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported that the patient had been sleeping at home and when last looked upon by her mother at 12:30am everything was fine; the freedom driver was plugged into wall power and was running normally.The customer also reported that at approximately 3:30am, the patient's mother heard a steady alarm from the freedom driver.The mother found the patient unresponsive with sputum around her mouth.The freedom driver had a beat rate display of "***" and there was no pumping noise coming from the driver.The customer also reported that the mother switched the patient to the backup freedom driver and the patient revived.The length of time from the mother hearing the alarm to switching drivers was reported to be 3-4 minutes.The customer also reported that the patient was lethargic with a headache and was admitted to the hospital where a ct scan was negative and no neurological deficits were reported.The patient was discharged home three days later, (b)(6) 2018, supported by the backup, now primary, freedom driver she was admitted on.The patient continues to be in stable health.

Manufacturer Narrative

The probable cause of the freedom driver stop was a fractured scotch yoke on the piston cylinder assembly.The location of the fracture indicated that the secondary motor gearbox was in operation when the scotch yoke failed.The scotch yoke fractured as a result of an overloading condition created by interference between the primary and secondary motor/gearboxes.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation of this complaint 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
• MDR Report Key: 7298009
• MDR Text Key: 101002935
• Report Number: 3003761017-2018-00062
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 20 YR