MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 595000-001

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

The freedom driver was not supporting a pt.A syncardia clinical support specialist reported that during a system check, the green light on the power adaptor while connected to the freedom driver would not illuminate when plugged into an external power source through the freedom a/c power supply.The freedom power adaptors and the green light on the freedom power adaptors did not illuminate.The freedom power adaptors functioned as intended when they were connected to other freedom drivers.This alleged failure mode poses a low risk to the pt because the issue was observed when the freedom driver was not supporting a pt.In addition, the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; ce 2655; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4563517
• MDR Text Key: 16542555
• Report Number: 3003761017-2015-00075
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/17/2015

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: Other
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• 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