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

Catalog Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 11/28/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited intermittent fault alarms for one to two days while supporting a pt.There was no reported adverse pt impact.The pt was subsequently switched to the backup driver.The customer reported that the pt was asymptomatic.Although the freedom driver exhibited intermittent fault alarms, the driver continued to function as intended.This alleged failure mode poses a low risk to the pt because it does 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 2502; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4359914
• MDR Text Key: 17999510
• Report Number: 3003761017-2014-00294
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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
• Patient Age: 53 YR