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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.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).

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a low battery alarm and the patient did not change the batteries or plug in the freedom driver into wall power before the freedom driver exhibited a fault alarm.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed an alarm code, 39 (speaker 2 voltage too high when on), that could have been the customer-reported fault alarm as it is caused by an intermittent connection of the batteries, or as a result of the battery exchange performed during the driver exchange.It is unable to be confirmed if this alarm was recorded before or after the patient switched drivers.The driver in "as received" condition passed all sections of functional testing.Additionally, a battery exchange test and a battery discharge/recharge test were performed on the driver, and it performed as intended.The onboard batteries used by the customer during the reported experience were not returned with the driver and could not be evaluated or used in the investigation.During investigation testing, a low battery alarm was reproduced when the onboard batteries dropped below 35% charge, but the alarm recovered, as designed, when the driver was connected to external power, and there was no evidence of a device malfunction.Only permanent fault alarms are recorded in the driver's alarm history; battery alarms or other intermittent and recoverable alarms are not recorded.The reported low battery alarm, turned into fault alarm, may not have been recorded prior to the patient switching drivers.The root cause of the customer-reported fault alarm could not be conclusively determined, but an unaddressed low battery alarm will turn into a fault alarm by design.Syncardia freedom driver operator manual, section 10.1 visual and audible alarms battery alarms contain a caution box which states: do not ignore a battery alarm.A battery alarm will turn into a fault alarm if it is not address and one or more onboard batteries drop below 30% charge.The driver performed as intended and there was no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) 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
• Manufacturer Contact: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 7099580
• MDR Text Key: 95667771
• Report Number: 3003761017-2017-00251
• 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,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• 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: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2012
• 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 Age: 48 YR