MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; ARTIFICIAL HEART

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

Event Type  Injury  

Event Description

Syncardia freedom driver was changed to backup freedom driver at 0145 beside in 8 cooley a bed 04.Prior to freedom driver exchange, css staff noticed the spring beneath the silver latch was laying horizontally instead of vertically.Css staff changed out the whole connector during the transition from one freedom driver to the backup freedom driver.New primary freedom driver sn: (b)(4) new backup freedom driver sn: (b)(4).Old freedom driver sn: (b)(4).Pt tolerated exchange well and no hemodynamic instability.Old freedom driver was collected and will be sent back to syncardia for analysis.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; tucson AZ 85713
• MDR Report Key: 6607429
• MDR Text Key: 76656236
• Report Number: MW5070136
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 72