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

Catalog Number 595000-001

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

The freedom driver was not supporting a patient.The customer reported that the connection 1 receptacle that attaches on the power adaptor fell into the freedom driver housing.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.

Manufacturer Narrative

(b)(4).

Event Description

This freedom driver was not supporting a patient.The customer reported that the connection 1 receptacle that connects the power adaptor to the freedom driver fell into the driver housing.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external components confirmed the reported issue that the connection 1 receptacle was broken and located inside the driver housing.The driver was tested and met all pressure test requirements associated with normotensive and hypertensive patient simulator settings with no anomalies or unintended alarms.The driver could not be tested for test steps that required the use of the connection 1 receptacle.The broken connection 1 receptacle prevented the freedom driver from being connected to an external power source.The root cause for the broken connection 1 receptacle was likely rough handling or impact shock.The driver was repaired and serviced and passed all final performance testing.This 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 has a redundant power source of onboard batteries, which can power the freedom driver without connection to an external power source.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.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 5375630
• MDR Text Key: 36917793
• Report Number: 3003761017-2016-00012
• Device Sequence Number: 1
• Product Code: LOZ
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2012
• 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