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

Model Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2016

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.In addition, it would not prevent the driver from performing its life-sustaining functions.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 reported that the freedom driver exhibited a fault alarm during checkout on a mock tank.

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed an abrasion on the front housing, fractured housing bosses with raised inserts, and the secondary motor cam follower out of bottom dead center (bdc).The driver's alarm history was reviewed and revealed one new alarm, a code 2d, secondary motor voltage too high.Since the secondary motor was out of the bdc positon, it is possible that it engaged and produced the customer-reported alarm.The driver passed all test sections and pressure performance metrics associated with normotensive and hypertensive settings with no anomalies or alarms on the primary motor.The driver was also tested on the secondary motor, where it passed all test sections related to pressure performance metrics.The cause of the customer-reported alarm is most likely operation of the secondary motor.Rough handling of the freedom driver may have moved the secondary motor out of the bottom dead center position, putting it in the path of the moving scotch yoke, causing the secondary motor to rotate.The driver sensed the rotation of the secondary motor, and then, as designed, alarmed and switched over to secondary motor operation.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.

Event Description

The freedom driver was not supporting a patient.The customer reported that the freedom driver exhibited a fault alarm during checkout on a mock tank.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6063783
• MDR Text Key: 59024110
• Report Number: 3003761017-2016-00360
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 10/28/2016
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1