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 Problems Death (1802); Respiratory Distress (2045); Loss of consciousness (2418)

Event Date 01/16/2015

Event Type  Death  

Event Description

The reported issue involves three freedom drivers and are reported under three separate medical device reports: freedom driver sn (b)(4) (mfr report # 3003761017-2015-00067); freedom driver sn (b)(4) (mfr report # 3003761017-2015-00068); and freedom driver sn (b)(4) (mfr report # 3003761017-2015-00069).The customer reported that all three freedom drivers exhibited fault alarms while supporting a pt at home.The customer also reported that the pt, who was at home, was unconscious with labored breathing when the first driver exhibited a fault alarm.The pt was transported to the emergency room at (b)(6) and switched to the second freedom driver.The second freedom driver exhibited a fault alarm and the pt was switched to the third freedom driver.Third freedom driver exhibited a fault alarm.The pt subsequently expired.

Manufacturer Narrative

The freedom drivers have been returned to syncardia for eval.An investigation has been initiated and preliminary results indicated that the drivers performed as intended and there is no evidence of a device malfunction.When the investigation has been completed, the results 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.; tucson, AZ 85713-2613 ; 5205451234
• MDR Report Key: 4538070
• MDR Text Key: 17333249
• Report Number: 3003761017-2015-00067
• 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: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• 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: 01/16/2015
• 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: 36 YR