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 Loss of consciousness (2418)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

The freedom driver was not returned to syncardia for evaluation.The freedom driver system guidebook for patients and caregivers refers to driveline kinks in several places including: glossary: a kink is caused when a driveline is bent resulting in decreased or no air flow through the driveline.Warnings: caution box - failure to adhere to the warnings listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.Do not allow the drivelines (or cannulae) to become kinked.If there is a fault alarm, immediately inspect the drivelines for kinks.Precautions and recommendations: caution box - failure to adhere to the precautions and recommendations listed below may cause the freedom driver system to malfunction or not perform the life-sustaining functions as designed.A sudden drop in cardiac output may be caused by a kink in the drivelines.Additional information 10.1.1 things you should never do caution box - do not kink, twist, step on or place objects on drivelines or cannulae.This may cause loss of air that is necessary to pump your tah-t.Activities that may cause pulling, twisting or kinking of the cannulae or drivelines.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed is evaluation of this complaint and is closing this file.

Event Description

The customer, a syncardia certified hospital, reported that the patient attempted to use the bedpan, with the assistance of his wife, when the freedom driver exhibited an alarm.A nurse passing by the room heard the alarm and found the patient with agonal breathing.The customer also reported the nurse called "code blue" then assessed the patient, drivelines and driver and found a driveline kink under the patient's leg.The kink was fixed and patient regained consciousness.The freedom driver alarm stopped but then resumed intermittently.The customer also reported that the patient's blood pressure (bp) was checked and was very high, 190/100.Hf/mcs team arrived on scene, assessed intermittent fault alarm as being caused by low cardiac output possibly related to extremely high bp.Antihypertensives were given to the patient and his bp normalized and the freedom driver was not exchanged.The customer also reported that the patient regained full awareness; no ct or other diagnostics were performed.

• 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: 7246400
• MDR Text Key: 99185975
• Report Number: 3003761017-2018-00027
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2017
• 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): Life Threatening
• Patient Age: 65 YR