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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.Ce 5316 initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent temperature alarms while supporting the patient.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

The customer-reported intermittent temperature alarms were unable to be confirmed or replicated.Temperature alarms are not recorded in the driver's alarm history unless they persist for at least 30 minutes.Review of the driver's alarm history did not reveal any alarm codes.The freedom driver passed all functional testing; including a 96-hour observation test with no abnormalities or recorded alarms.The root cause of the customer-reported issue could not be conclusively determined.The freedom driver performed as intended with no evidence of a device malfunction.This issue will be monitored and trended as part of the customer complaint 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
• Manufacturer Contact: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10286465
• MDR Text Key: 204975695
• Report Number: 3003761017-2020-00155
• 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: 06/29/2022

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: Lay User/Patient
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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: 60 YR
• Patient Sex: Male