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

Catalog Number 595000-001

Device Problems Component Falling (1105); Pumping Stopped (1503)

Patient Problems Fall (1848); Head Injury (1879); Loss of consciousness (2418)

Event Date 02/21/2015

Event Type  Injury  

Event Description

The customer reported that the pt dropped his freedom driver while getting ready to shower.The customer also reported that according to the pt, the driver stopped pumping for five seconds and then started back up again.The customer also reported that the pt lost consciousness and as a result, he fell and hit his head.The customer also reported that the pt regained consciousness once the driver started back up again.The pt subsequently switched to the backup freedom driver and went to the hosp.The pt was evaluated at the er.The customer reported that a ct scan of the patient's head and neck was performed and the results showed no neurological deficits.The customer also reported that following the eval, the pt was discharged to home and is doing well.

Manufacturer Narrative

Although the freedom driver reportedly stopped for five seconds after being dropped, the driver started pumping after a few seconds and continued to perform 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: carol marcot, esq. vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4627104
• MDR Text Key: 20458778
• Report Number: 3003761017-2015-00089
• 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: 02/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• 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: 02/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2012
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR