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

Model Number 595000-001

Device Problems Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 11/09/2020

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.Ce (b)(4); initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently changed to a backup driver.

Manufacturer Narrative

Visual inspection of the driver revealed the secondary motor's cam follower out of the bottom dead center (bdc) position.A '2d' fault alarm was recorded in the driver's eeprom.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 reported alarm and it 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.The customer-reported fault alarm was unable to be reproduced during the investigation as the driver did not run on the secondary motor.Despite the observed secondary motor cam follower moved out of bdc position, functional testing confirmed that the driver functioned as intended.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.(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: 10886304
• MDR Text Key: 220722621
• Report Number: 3003761017-2020-00241
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR