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

Model Number 595000-001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom driver onboard battery latch was not working.

Manufacturer Narrative

Visual inspection of the driver revealed physical damage to the front and rear housings.In an attempt to reproduce the customer-reported issue, a dummy battery extraction test was performed on the driver.Without inserting an onboard battery, the dummy battery was removed from the driver's left battery well and inserted in the right battery well, and then again removed from the right battery well, thus confirming the customer-reported issue.It is possible to remove a dummy battery if the dummy battery is wiggled enough.This is due to its skeleton structure and lack of walls or skin.However, the purpose of the dummy battery is to be able shut down a freedom driver that is not in use and the dummy battery should only be removed from the backup freedom driver after inserting an onboard battery.It is not proper procedure to remove the dummy battery without a freedom battery in the freedom driver and it is advised against per f-900013-en, freedom driver system operator manual - us.Section 1.3.13 dummy battery states the following: · the dummy battery should only be removed from the backup freedom driver after inserting an onboard battery when switching the primary freedom driver to the backup freedom driver because of a fault alarm that cannot be resolved.The driver passed all sections of functional testing and performed 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 of this complaint 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: 9411051
• MDR Text Key: 169210868
• Report Number: 3003761017-2019-00353
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/21/2019
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 11/18/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1