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

Model Number 595000-001

Device Problems No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results 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 did not pass the system check out on the first attempt; it alarmed immediately when the batteries were installed.This occurred for two more attempts and then the driver did pass the system check, however, the customer returned it for evaluation.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed two fault codes, a 39 and 2d.The 39 fault code can be produced when batteries are exchanged too quickly and the 2d fault code suggests that the secondary motor system was engaged in the field.However, there was no visual evidence of secondary engagement.Because the customer-reported issue occurred during battery installation, an onboard battery exchange test was performed and the driver did not alarm.During investigation testing, the freedom driver performed as intended with no evidence of a device malfunction.The root cause of the customer-reported alarms could not be conclusively determined.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation 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 (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 12433824
• MDR Text Key: 270201120
• Report Number: 3003761017-2021-00177
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

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: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2017
• 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