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

Model Number 595000-001

Device Problems Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2019

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 did not pass system check out procedure because the driver did not start when putting the battery in and the display showed asterisks and after a short while enunciated an alarm.

Manufacturer Narrative

Visual inspection of the driver revealed that the driver's secondary motor's cam follower was out of the bottom dead center (bdc) position.This is typically indicative of secondary motor engagement.The driver's alarm history was reviewed and revealed an alarm, a '12' code, which is produced by the top piston cylinder assembly (pca) sensor not detecting any movement for five seconds.After a '12' alarm, the secondary motor will always engage.During investigation testing, the customer-reported issue was able to be reproduced as the primary motor did not engage and the driver functioned as intended by switching to the secondary motor system and enunciating an alarm as designed.The root cause was determined to be the inability of the main printed circuit board assembly (pcba) to operate the primary motor.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: 9214157
• MDR Text Key: 163064048
• Report Number: 3003761017-2019-00305
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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: 10/16/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR