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

Catalog Number 595000-001

Device Problems Fracture (1260); Audible Prompt/Feedback Problem (4020)

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

Event Date 01/23/2023

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 the driver had a long-lasting red continuous alarm.The patient was switched to a back-up driver.The patient was also reported to be in bad condition before and after the driver exchange, and that there is no information as to whether the patient condition contributed to the alarm.

Manufacturer Narrative

Alarm history and patient data file review identified one new alarm in the freedom driver's alarm history: code 0f bottom dead center time out.This alarm is produced when the bottom dead center sensor has an open/short for four consecutive readings.If the driver is already in operation, supporting the patient, this alarm could be produced as a result of the primary motor halting, then the driver's operation would revert to secondary system.Since no signs of secondary motor engagement were observed and no pause in operation was reported; this alarm was likely produced in house during the last service of the driver.Because it is unlikely this is the alarm experienced by the patient, the complaint was not confirmed and was unable to be replicated.Patient condition was reported as "bad condition before and after the alarm".Visual inspection of internal components revealed a fractured, bottom right rear housing boss.No signs of secondary motor engagement were observed.Visual inspection of external components revealed a broken fan cover and a fracture on the display cover.This damage would not contribute to an alarm condition.Freedom driver passed all incoming functional testing.Additional testing included a 7-day observation run at normotensive settings in an attempt to reproduce the customer reported alarm.Testing was not able to replicate the condition and no fault alarms occurred during the observation test.Failure investigation for this complaint could not confirm the reported issue via alarm history data nor functional/observational testing.The complaint was not replicated via functional or observational testing.The root cause of the customer reported alarm could not be conclusively determined.Failure investigation identified no test failure, damage, or abnormalities that could have contributed to the reported alarm.Driver functioned as intended.Patient was switched to a back-up driver without reporting adverse impact.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.).(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: 16309077
• MDR Text Key: 308950149
• Report Number: 3003761017-2023-00012
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• 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
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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: 58 YR
• Patient Sex: Female