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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

Patient Problem Loss of consciousness (2418)

Event Date 01/22/2019

Event Type  Injury  

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 patient was in physical therapy when the freedom driver exhibited a fault alarm and stopped working.The customer also reported that the patient lost consciousness.The customer also reported that the patient was immediately switched to a backup driver and transferred to the emergency room.The customer also reported that the patient had reported feeling dizzy at physical therapy prior to the alarm.Though the patient did lose consciousness, the customer also reported the patient was sitting on a bench and did not fall or sustain trauma during the event.

Manufacturer Narrative

Visual inspection of the driver revealed a broken connector on external power to main cable, scuffs marks on main printed circuit board assembly (pcba) and the primary motor, and damaged pins on the left battery pcba.The root cause of the damaged external connector cannot be conclusively determined, but is likely the result of excessive extraction force being applied with disconnecting the power adaptor from the driver, or as a result of rough handling/impact shock, as evidenced by the visual inspection finding.Despite the damaged external connector, the driver passed all functional testing.Additionally, the driver was subjected to an extended observation run where it functioned as intended with no alarms, abnormalities, stops or pauses.Further evaluation of the left battery board determined that the observed damaged/bent pins would not have an impact to the functionality of the board or the driver, thus are not a contributing factor to the reported issue.During investigation testing, the customer-reported issue of a reported driver stop following an alarm was not reproduced.No other components or accessories were returned with the driver and therefore could not be evaluated.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 4651 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: 8310664
• MDR Text Key: 135174997
• Report Number: 3003761017-2019-00026
• 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
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR