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 10/16/2021

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 nurse reported that it occurred after the patient sneezed.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Visual inspection of the driver revealed damage to the scotch yoke, fan cover and front housing and the secondary motor's cam follower out of the bottom dead center (bdc) position.The driver's alarm history was reviewed and revealed three '2d' fault alarm codes.This alarm is produced as a result of the operation of the secondary motor.Since the secondary motor was observed to be out of the bdc position, it is likely that this is the customer-reported alarm and was produced because of secondary motor engagement.The conditions that caused the secondary motor cam follower to move out the bdc position cannot be conclusively determined, but it is possible that it occurred due to a drop, near drop, or other rough handling of the driver.It could have also been caused by a jolt to the driver during the patient's sneezing episode.In an attempt to reproduce the customer-reported issue, valsalva maneuver tests were performed at normotensive and hypertensive conditions and the driver functioned as intended.No permanent alarms were produced during these tests.Despite the observed secondary motor cam follower moved out of bdc position, functional testing confirmed that the driver functioned as intended on both the primary and secondary motor circuits.The driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.Ce 5680 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: 12700945
• MDR Text Key: 281416663
• Report Number: 3003761017-2021-00206
• 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: 01/11/2022

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: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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: 52 YR
• Patient Sex: Female