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 11/03/2020

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.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent fault alarms and low cardiac output values while supporting the patient.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 did not reveal any recorded alarms.Only permanent alarms are recorded in the drivers alarm history as intermittent and / or recoverable alarms are not recorded in the driver alarm history.The freedom driver passed all functional testing; including a 48-hour observation test with no abnormalities or recorded alarms.In an attempt to reproduce the customer-reported low cardiac output, a valsalva maneuver test at both normotensive settings and hypertensive settings was performed on the driver.During these tests, the driver performed as expected with no evidence of a device malfunction.The root cause of the customer-reported intermittent alarms and low cardiac output values could not be conclusively determined.Details pertaining to the patient condition were not provided by the customer.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.Ce 5428 comp-(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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10950324
• MDR Text Key: 222922294
• Report Number: 3003761017-2020-00253
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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: 33 YR
• Patient Sex: Male