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

Model Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a 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 customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm during an onboard battery exchange.

Manufacturer Narrative

The driver's alarm history was reviewed and no alarms were found recorded in the driver's eeprom.Only permanent alarms, alarms lasting more than 4 minutes and 15 seconds, are recorded in the eeprom.Intermittent and/or recoverable alarms would not be recorded.Visual inspection of the driver revealed a small piece of metal wire inside the right battery well.Functional testing was not performed with the wire in the battery well because of the risk of a short that could potentially damage the driver or onboard batteries.An onboard battery exchange test was performed using nine onboard batteries that have previously passed syncardia's acceptance criteria.No alarms were produced during this test.During investigation testing, the customer-reported issue could not be confirmed.Because of the potential risk of damage to the driver and onboard batteries, it could not be conclusively determined if the foreign object found in the right battery well was the root cause of the customer-reported alarm during an onboard battery exchanged.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: 9214973
• MDR Text Key: 163063851
• Report Number: 3003761017-2019-00300
• 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: 01/27/2020

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: 10/07/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1