MAUDE Adverse Event Report: SYNCARDIA SYNCARDIA; FREEDOM DRIVER

Device Problems Device Alarm System (1012); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Loss of consciousness (2418)

Event Date 07/30/2016

Event Type  Injury  

Event Description

At approximately 0905 on (b)(6), patient (b)(6) was in his garage moving boxes (less than 10 lbs).He reports and wife confirmed, that freedom driver "shut off" without any alarms prior to shutting down.Wife described that patient collapsed down shortly after screaming out that his "pump stopped".His wife ran to his side and was yelling out his name.She said approximately 45 seconds passed and then the driver "restarted with a short alarm and then began pumping normally" and patient regained consciousness.Confirmed with patient and wife that both batteries in his driver were fully charged when this event occurred.Readings at time of call on driver that shut off: br 133, pv 48.9, co 7.As they were getting ready to switch out his driver, they noticed that they were unable to do the switch out due to a dislodged spring in the red cannula.Both patient and his wife were too anxious and didn't feel safe switching and the wife drove patient to (b)(6) emergency room.On arrival to er i noticed that both springs on red and blue adaptor were displaced and this made the adaptors not functional.I replaced both adaptors completely when i switched out his freedom driver.Patient was admitted for further medical work up.Analysis of the driver revealed that the screw length is too small which can be dislodged and cause a short circuit and cause the batteries to go in power surge mode and shut down for about 20-45 seconds.Syncardia made a minor design enhancement to change the screw to a longer length to all the drivers going forward.

• Brand Name: SYNCARDIA
• Type of Device: FREEDOM DRIVER
• Manufacturer (Section D): SYNCARDIA; tucson AZ
• MDR Report Key: 6016918
• MDR Text Key: 57151766
• Report Number: MW5065269
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 92