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

Catalog Number 595000-001

Device Problems Break (1069); Audible Prompt/Feedback Problem (4020)

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

Event Date 06/13/2022

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.

Event Description

The customer, a syncardia authorized distributor, reported a fault alarm on freedom driver while patient was sitting at home.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Two new alarms were recorded in the driver's alarm history, first fault code is likely the alarm produced by the reported event, and the second fault code occurs as a result of secondary motor engagement.No evidence of secondary motor engagement was observed, this alarm was likely produced in house during alarm history data extraction prior to functional testing.The first fault code alarm is produced because of a change in voltage detected during operation of the driver which can occur due to shaking or impact to the driver or a sudden peak in the primary motor's current can cause this alarm.Visual inspection of external components found there was a missing rubber foot on the front housing right side, a broken fan cover, a broken display cover, cracked rear housing, and a stain on air filter origin unknown.Visual inspection of internal components revealed grease stain on primary motor which is cosmetic in nature and does not impact functionality.Freedom driver passed all incoming functional testing.In an attempt to reproduce the reported alarm, a battery exchange test was performed on the driver and a new alarm was produced.This new alarm is expected when performing a battery exchange test.The first alarm fault code could not be duplicated.A 72 hour observation run at normotensive settings was performed to try and reproduce the first fault alarm.Testing was not able to replicate the condition, no fault alarms occurred during the observation test.Failure investigation for this complaint confirmed the reported issue via alarm history data review.The first fault code alarm was not replicated via functional testing nor observational testing and there was no evidence of a device malfunction.The root cause of the fault alarms could not be conclusively determined.Failure investigation identified damage and abnormalities that could have contributed to the patient reported fault alarms.Driver functioned as intended.(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: 14951110
• MDR Text Key: 296010102
• Report Number: 3003761017-2022-00063
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2018
• 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: 55 YR
• Patient Sex: Male