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

Model Number 595000-001

Device Problems Device Displays Incorrect Message (2591); Reset Problem (3019); Audible Prompt/Feedback Problem (4020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver paused momentarily then restarted with a fault alarm while supporting a patient.The customer also reported that the patient subsequently switched to a backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

During investigation testing, the customer-reported driver pause and restart with fault alarm was not able to be reproduced, but was partially confirmed.The cause of the customer-reported issue was the driver switching to secondary motor operation.The driver most likely switched to secondary motor operation because of an increased load of the motor gearbox assembly, increasing resistance in the system, which possibly led to the piston not being able to move, triggering the driver to switch to secondary operation.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce 4297 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: 7492720
• MDR Text Key: 108146163
• Report Number: 3003761017-2018-00196
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR