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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm upon start up.

Manufacturer Narrative

Visual inspection of the driver revealed that the driver had a broken fan cover and scotch yoke.The secondary motor was also found to be out of the bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed one new alarm, 2d fault code.Since signs of secondary motor engagement were observed during the incoming visual inspection, it is likely that this is the customer-reported alarm as the 2d fault code is produced because of the engagement of the secondary motor.The cause of the secondary motor engaging (which caused the customer-reported alarm) could not be determined, but may have been caused by impact shock, rough handling or a near drop (jolt).During investigational testing, the driver initially was operating on the primary motor, but no pumping was produced.The driver then reverted to its secondary system, producing a permanent fault alarm.Both motors functioned as intended; however, due to the broken scotch yoke, no pumping was produced.The freedom driver's scotch yoke was then replaced and functional testing was performed again in order to isolate the issue to the broken scotch yoke.The driver passed all sections of functional testing with the replaced scotch yoke.When the secondary motor cam follower is out of bdc position, it is in the pathway of a moving scotch yoke.While out of bdc, the secondary cam follower was struck by the moving scotch yoke, which would cause the scotch yoke to break.A broken scotch yoke would prevent the driver from pumping.The driver then sensed the rotation of the secondary motor cam follower and switched to the secondary motor operation, per design.When operating on the secondary motor system, the driver will sound a fault alarm.It cannot be conclusively determined how the secondary motor cam follower initially moved out of bdc, or when the scotch yoke broke.The issue of broken scotch yokes is being addressed in a corrective and preventative action plan (capa).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: 9267072
• MDR Text Key: 164679961
• Report Number: 3003761017-2019-00312
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• 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: 10/25/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1