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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problems Loss of consciousness (2418); Patient Problem/Medical Problem (2688)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the patient's freedom driver had been exhibiting fault alarms at home.The patient had a fever and came to the hospital to get laboratory tests.After the blood draw, the patient reported not feeling good and the freedom driver exhibited a continuous fault alarm.The patient experienced tunnel vision and became unresponsive.The patient was switched to a backup driver.No alarms were observed after the driver switch.The customer also reported that the patient exhibited low fill volumes and low cardiac output on the primary and replacement freedom drivers.The customer also reported that the patient was subsequently switched to a companion 2 driver and transferred to the emergency room.

Manufacturer Narrative

The customer-reported issues of fault alarms and low cardiac output/fill volumes were not able to be confirmed.The driver in "as received" condition passed all incoming functional test requirements.Additionally, an extended observation run test was performed at normotensive settings and the driver performed as intended with no abnormalities or alarms.An alarm was able to be reproduced during investigation testing when the mock tank was manually adjusted to decrease the volume of the right atrial pressure chamber below normotensive values to reproduce a hypovolemia condition.A possible cause for the reported alarms experienced by the patient could be attributed to the patient conditions.An alarm for a possible patient condition (hypovolemia, low cardiac output) will only record as a fault alarm in the alarm history after 4 minutes, 15 seconds of continuous alarm conditions without resolve.The driver performed as intended and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.

Event Description

The customer reported that the patient did not lose complete consciousness.The patient reported she had "tunnel vision".Her eyes were open the whole time according to her husband, but when he asked her if she was okay, she did not respond.Patient recalled her husband asking her if she was okay, but said she was unable to respond.The customer also reported that after the patient was moved to the icu she began to feel better.Patient did have a small drop in her hemoglobin but denied any hematochezia or melena.

• 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: 8847576
• MDR Text Key: 152899389
• Report Number: 3003761017-2019-00228
• 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: 08/08/2019

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: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR