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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Audible Prompt/Feedback Problem (4020)

Patient Problem Loss of consciousness (2418)

Event Date 07/07/2019

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)- initial.

Event Description

The customer, a syncardia authorized distributor, reported that the patient was performing routine morning activity under supervision of the nurses in the clinic when the freedom driver exhibited a continuous fault alarm.Clinic staff checked the freedom drivelines, connections and the patient's blood pressure but found nothing wrong.After the inspection, the freedom driver suddenly stopped working and was recognized immediately and the patient was switched to the backup driver.The customer also reported that the patient briefly lost consciousness but recovered quickly after the driver switch and there was no permanent health impact.

Manufacturer Narrative

The customer-reported fault alarm followed by a driver stop was not able to be confirmed or reproduced during investigation testing.The driver's alarm history was reviewed and revealed one new alarm fault code.This 2d fault code was likely produced at syncardia during the last service of the driver as there was no evidence of secondary motor engagement.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent and/or recoverable alarms are not recorded.The driver in "as received" condition passed all sections of functional testing.Additionally, an extended, seven day observation run was performed on the driver where it performed as intended with no abnormalities, alarms, interruptions in operation, or burning smells.The onboard batteries returned with the driver and associated with being in use by the patient were each individually evaluated and each passed all sections of the freedom onboard battery evaluation procedure.The driver and onboard batteries performed as intended with no evidence of a device malfunction.The root cause of the customer-reported issue could not be determined.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.Ce 4880 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: 8847579
• MDR Text Key: 152846537
• Report Number: 3003761017-2019-00226
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• 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: 07/22/2019
• Date Manufacturer Received: 07/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR