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

Model Number 595000-001

Device Problems Filling Problem (1233); Device Displays Incorrect Message (2591)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2017

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, it 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).Initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent alarms after the patient returned indoors from playing basketball (outside temperature approximately 20f).The customer also reported that the patient had elevated fill volumes and cardiac output with no symptoms or complaints of not feeling well.The customer also reported that after sometime the freedom driver exhibited a permanent fault alarm.The customer also reported that the patient was switched to a back-up freedom driver without any reported adverse patient impact.

Manufacturer Narrative

The driver in "as received" condition passed all test requirements and pressure performance metrics associated with normotensive and hypertensive settings.The driver's alarm history was reviewed and revealed four alarm codes.While it cannot be conclusively determined what caused each of the recorded alarms, the customer-reported fault alarms could not be reproduced during investigation testing.The driver functioned as intended with 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
• MDR Report Key: 7121652
• MDR Text Key: 95908551
• Report Number: 3003761017-2017-00254
• 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
• 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: 12/15/2017
• 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: 12/22/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR