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

Model Number 595000-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Low Cardiac Output (2501)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

The freedom driver was returned to syncardia for evaluation.The customer-reported issue of intermittent alarms for low cardiac output could not be confirmed, as the driver's alarm history does not record intermittent or recoverable alarms.The driver in "as received" condition passed all incoming functional test requirements with no issues or alarms.An extended observation run was performed on a 50 cc mock tank, during which the driver performed as intended with no unintended alarms or anomalies.The mock tank was then set to hypovolemic settings, and under these circumstances when cardiac output decreased below 3.5 lpm, the freedom driver exhibited a low cardiac output alarm as designed.The customer-reported low cardiac output alarm was reproduced.A possible cause for the reported alarm experienced by the patient could be attributed to the patient conditions.An alarm for low cardiac output (below 3.5 lpm) would not record as a fault alarm in the driver alarm history until 4 minutes, 15 seconds of continuous alarm conditions without resolve.There is no evidence of an alarm related to low cardiac output recorded in the driver's alarm history, and it is not known if the patient experienced prolonged low cardiac output conditions.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) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent low cardiac output alarms while supporting a patient.The customer also reported that the patient's fill volumes were mostly in the high 30s to low 40s but were dropping into the 20s about once an hour.The customer also reported that the patient had stopped diuretics and her beat rate had recently been adjusted to 135 bpm.The customer also reported that the patient received 500 cc ivf in transit to hospital and had no more alarms from the freedom driver.The customer also reported that the patient's laboratory results did not indicate that she was dry, however, patient continued to drink 2-3 liters of gatorade.The customer also reported that the patient was subsequently switched to a back-up freedom driver without any adverse patient impact.The customer also reported that the patient was discharged later the same day of this event.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7041647
• MDR Text Key: 92352296
• Report Number: 3003761017-2017-00206
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR