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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

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

Event Date 08/19/2021

Event Type  malfunction  

Event Description

The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the patient's backup freedom driver alarmed immediately the moment the battery was put in.

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Manufacturer Narrative

The driver's alarm history file was reviewed and revealed fault codes "22" and "39" which can occur when an onboard battery is removed too quickly, not giving enough time for the system to recognize the first onboard battery has been inserted in the driver, or if the second onboard battery is not properly inserted and produces an intermittent communication.These are most likely the alarms experienced by the customer.During the functional testing, the driver did not meet performance specifications due to the right-side speaker printed circuit board assembly (pcba) values being under the specified db requirements of 75-90 db; this was attributed a malfunction of the speaker pcba, which is unrelated to the customer-reported issue.(section h6 codes 1198, 427, 120, 4307).In an attempt to recreate the customer-reported alarm battery exchange testing was performed using eight different freedom onboard batteries.The testing demonstrated that the driver functioned as intended and the customer-reported issue was not able to be reproduced.The conditions that caused the driver to annunciate a fault alarm cannot be conclusively determined.(section h6 codes 3189, 213, 67).F-900013-en, rev 006, freedom driver system operator manual, section 1.3.8, onboard batteries, instructs the user to wait five seconds between replacing the first battery and removing the second one.This ensures that the replacement battery has activated and is sourcing power to the freedom driver.Otherwise, a permanent fault alarm can be triggered.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: 12409206
• MDR Text Key: 281416080
• Report Number: 3003761017-2021-00176
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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
• Patient Age: 50 YR
• Patient Sex: Female