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 07/29/2020

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.(b)(4).

Event Description

The customer, a syncardia certified hospital, reported that while on dialysis, the patient sneezed and the freedom driver exhibited a fault alarm.There was no reported adverse patient impact.The customer also reported that the patient was switched to the backup freedom driver.

Manufacturer Narrative

Visual inspection of external components identified minor cosmetic damage to the display cover and exhaust fan cover.Damage is not related to the fault alarm.Visual inspection of internal components found no evidence of damage or abnormalities.The driver passed all incoming functional testing.Review of alarm history data found one new alarm recorded in the driver's alarm history which can occur as a result of secondary motor engagement or as a result of functional testing.No evidence of secondary motor operation was found during inspection.In an attempt to reproduce the customer-reported experience as described, a valsalva maneuver test at both normotensive settings and hypertensive settings was performed on the driver.During these tests, the driver performed as intended, enunciating an alarm due to low cardiac output and recovering after a few seconds.No permanent alarms were produced as a result of these tests.Testing performed as part of the investigation was unable to reproduce the customer-reported issue and there was no evidence of a device malfunction.The failure investigation was not able to confirm or replicate the customer reported fault alarm.There was no evidence of a device malfunction.The root cause of the customer-reported alarm could not be determined.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.Ce 5330 (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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 10449464
• MDR Text Key: 204247285
• Report Number: 3003761017-2020-00168
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• 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: 46 YR
• Patient Sex: Male