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

Model Number 595000-001

Device Problems Electrical /Electronic Property Problem (1198); Audible Prompt/Feedback Problem (4020)

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

Event Date 09/09/2021

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 customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.The patient denies any rough handling to the freedom driver, sneezing, coughing etc.The patient's bp at the time was 107/69 and the driver beat rate changed from 130 bpm to 125 bpm.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

The driver's alarm history was reviewed and revealed two fault codes, 12 and 2d.A 12 fault code indicates the primary motor did not engage for greater than 5 seconds and a 2d fault code indicates the secondary motor had too high of a voltage (due to operation).These were most likely the customer-reported fault alarms.The freedom driver did not pass incoming functional test requirements as the main board did not provide power to the primary motor and therefore the system switched to the secondary motor as designed.Once the driver had switched to the secondary motor, the system sounded an alarm also as designed.This confirmed the customer-reported fault alarm.For the extended observation testing, the main board was replaced with a known functioning main board and the driver passed all functional test requirements.The root cause of the customer-reported fault alarm was determined to be a malfunctioning main board which was unable to operate the primary motor which caused the secondary motor to engage and sound the fault alarm.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: 12555587
• MDR Text Key: 274072008
• Report Number: 3003761017-2021-00191
• 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: 12/14/2021

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: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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: 41 YR
• Patient Sex: Male