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 10/22/2019

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 authorized distributor, reported that the freedom driver exhibited a fault alarm upon start up.

Manufacturer Narrative

Visual inspection of the driver revealed stress fractures on the display cover and fan cover and the secondary motor out of the bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed four new alarms, 2d fault code.Since signs of secondary motor engagement were observed during the incoming visual inspection, it is likely that these are the customer-reported alarms as the 2d fault code is produced because of the engagement of the secondary motor.One alarm is recorded each time the driver is power cycled after the secondary motor is out of bdc position.The driver in "as received" condition passed all sections of incoming functional testing.Additionally, since the secondary motor of the driver was observed to be out of bdc position, a functional test was performed on the secondary system.The driver functioned as expected while operating on the secondary motor system and sounded a fault alarm as designed.The root cause of the secondary motor engaging (which caused the customer-reported alarms) could not be determined, but may have been caused by impact shock as a result of rough handling as evidenced by the observe damage or a near drop (jolt).The driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.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: 9266858
• MDR Text Key: 164682202
• Report Number: 3003761017-2019-00320
• 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: distributor,foreign
• 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: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1