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 High Blood Pressure/ Hypertension (1908); No Consequences Or Impact To Patient (2199)

Event Date 01/11/2020

Event Type  malfunction  

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).

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was hypertensive.The customer also reported that the patient was switched to the companion 2 driver.There was no reported adverse patient impact.

Manufacturer Narrative

The driver's alarm history was reviewed and did not reveal any new alarms.Only permanent alarms are recorded in the driver's alarm history, intermittent and/or recoverable alarms are not recorded.During investigation testing, the driver passed all sections of functional testing without any alarms or abnormalities and there was no evidence of a device malfunction.Additionally, the driver was tested to simulate a valsalva maneuver and hypervolemic conditions (outside of normotensive values).The donovan mock tank was then adjusted by performing a valsalva maneuver and increasing the height of the systemic vascular resistance chamber until the aortic pressure was outside of normotensive values (184 mmhg), at which time the driver exhibited an alarm as designed when cardiac output was less than 3.5 lpm.This alarm cleared when cardiac output increased over 3.5 lpm.A possible cause for the customer-reported alarm could be attributed to patient conditions.An alarm for a possible patient condition (hypertension, low cardiac output (below 3.5 lpm)) records as a fault alarm in the drivers' alarm history after 4 minutes, 15 seconds of continuous alarm conditions without resolve.This aligns with the customer-reported patient hypertension at the time of the fault alarm.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 5159 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: 9668118
• MDR Text Key: 178001623
• Report Number: 3003761017-2020-00046
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• 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: 01/17/2020
• Date Manufacturer Received: 01/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR