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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)

Patient Problems Loss of consciousness (2418); Hypervolemia (2664)

Event Date 04/02/2020

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.Ce (b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the patient was found unresponsive at home with freedom driver alarming for low cardiac output.The patient's spouse switched him to a backup freedom driver which also displayed a fault alarm (mfr report # 3003761017-2020-00112).The spouse called ems who administered lasix and epi at the residence and called life flight.The patient regained consciousness prior to transfer and was appropriately responding to commands.Once at the hospital, the patient was transitioned to a companion 2 driver without incident.The customer also reported that the patient was severely volume overloaded with a cardiac output of 9.0 l/min.After four days, the patient's cardiac output was down to 7.2 l/min and his blood pressure was in check.

Manufacturer Narrative

Visual inspection of the driver revealed no anomalies that would indicate a device malfunction.The recorded '49' fault code in the driver's alarm history is likely the customer-reported alarm.The customer-reported issue of a low cardiac output alarm was reproduced during additional simulation testing when the mock tank was adjusted to simulate the patient's reported hypervolemic condition.The cause of the alarm was due to the displayed low cardiac output which was caused by the malfunction of the flow sensor.Despite the malfunction of the airflow sensor, the driver was able to continue providing life-sustaining functions and provide appropriate cardiac output.It cannot be conclusively determined what caused the patient to lose consciousness but it was possibly due to hypervolemic conditions as the patient was reportedly volume overloaded (cardiac output of 9 lpm) when he was connected to the companion 2 driver in the hospital.This aligns with the simulation testing as the driver was able to continue pumping despite the malfunction of the airflow sensor which led to an inaccurately displayed cardiac output (and subsequent alarm).A clinical assessment was performed by a syncardia clinical research associate and concluded that the patient's elevated fluid status could have contributed to increased systemic vascular resistance that may have inhibited the freedom driver from adequately pumping blood and led to the unconscious state.The freedom driver system is contraindicated for use in tah-t patients who are not clinically stable.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5261 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: 9967834
• MDR Text Key: 188659054
• Report Number: 3003761017-2020-00111
• 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: 04/06/2021

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: 04/17/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR