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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue did not prevent the driver from performing its life-sustaining function.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 had been in the patient's car in approximately 19 degree fahrenheit temperatures for 2.5 hours on (b)(6) 2018 prior to being put on patient support on (b)(6) 2018.The patient was switched to a companion 2 driver for medical management on (b)(6) 2018.The customer also reported that when attempting to shut down the freedom driver, the dummy battery was inserted - and appropriately seated, but the second freedom onboard battery was not able to be removed.The mechanical release was not functioning and staff needed significant effort to remove the battery.

Manufacturer Narrative

The customer-reported issue of a malfunction of the battery latch on the driver was confirmed during visual inspection when it was observed that the battery safety latch was broken inside of the right battery well.The broken battery safety latch in the right battery well would not allow for the removal of the left onboard battery, confirming the customer-reported issue.Despite the broken battery safety latch, the driver passed all pressure test requirements associated with normotensive and hypertensive settings.The root cause of the broken battery safety latch could not be conclusively determined.The reported temperature that the driver and onboard batteries were exposed to was outside of the recommended operating range (below 40°f for the driver and 32°f for the onboard batteries), but within the transportation/storage temperature range which goes down to -13°f.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 PNUEMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8148377
• MDR Text Key: 129902832
• Report Number: 3003761017-2018-00551
• 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
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• 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: 12/05/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR