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

Catalog Number 595000-001

Device Problems Appropriate Term/Code Not Available (3191); Audible Prompt/Feedback Problem (4020)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

The customer, a syncardia authorized distributor, reported that a few minutes after the freedom driver was connected to the patient, the driver had a red alarm.The patient was switched to a back-up driver.

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Manufacturer Narrative

Alarm history and patient data file review found seven new fault alarms recorded in the driver's eeprom: 2d, 36, 22, 4a, 28, 4a, and 4b which are related to peaks/drops in voltage or low pressure.Visual inspection of internal and external components revealed no abnormalities.Freedom driver passed all incoming functional testing.Additional observational focused on the most recently recorded alarm in the driver's eeprom; fault alarm code 4a: low cardiac output.The driver is powered on but not connected to a mock tank in order to test for cardiac output below 3.5 lpm and operated for 15 minutes, when the driver is designed to annunciate the alarm.The driver was then allowed to run for an additional 30 seconds while in the alarm state.A second eeprom extraction was performed and a new 4a fault code alarm was recorded.Failure investigation for this complaint confirmed the reported issue via alarm history data review.The complaint was not replicated via observational testing and no evidence of a device malfunction was found.The root cause of the customer reported issue could not be determined.Failure investigation identified no test failure, damage, or abnormalities that could have contributed to the customer reported alarm.Driver functioned as designed.Patient was switched to a back-up driver without any reported 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.) 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16224415
• MDR Text Key: 307948225
• Report Number: 3003761017-2023-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

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 Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• 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: 51 YR
• Patient Sex: Male