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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue did not prevent the freedom driver from performing its life sustaining function.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that a patient on the freedom driver at home felt lightheaded and called out for help.The customer also reported that the patient's freedom driver stopped without any alarms then restarted with alarms.The customer also reported that the patient's caregiver quickly switched the patient to a backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The customer-reported issue of the driver pausing/stopping and restarting with a fault alarm was confirmed via review of the driver's alarm history and testing.The alarm history was reviewed and revealed alarm codes produced as a result of the primary motor not engaging for greater than or equal to 5 seconds after continuous open or short detected.During investigation testing, the driver started up on the secondary motor and enunciated an alarm as designed.The root cause of the customer-reported issue was determined to be a malfunction of the main printed circuit board assembly (pcba) not powering the primary motor piston cylinder assembly (pca) triggering the driver to convert to secondary motor operation.This led to engagement of the secondary motor, which aligns with the reported brief pause in operation while switching over, and then starting back up with a fault alarm.Syncardia has a corrective and preventive action (capa) for this issue.Syncardia has completed its evaluation and is closing this file.Ce 4592 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: 8186733
• MDR Text Key: 131311580
• Report Number: 3003761017-2018-00555
• 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
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• 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: 12/03/2018
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR