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

Catalog Number 595000-001

Device Problem Audible Prompt/Feedback Problem (4020)

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

Event Date 06/18/2022

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 supporting a patient.The display showed asterisks instead of values for cardiac output and fill volume.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Device history file (dhf) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found two new alarms regarding cardiac output being low enough to trigger a permanent time-out.Visual inspection of external components found no abnormalities.Visual inspection of internal components found no abnormalities.Freedom driver passed all functional testing at incoming inspection.An additional, extended observational test was run with no resulting alarms or irregularities.A valsalva maneuver test was also performed to replicate customer reported complaint.Driver exhibited an out of range cardiac output and an alarm that recovered after approximately 20 seconds.No permanent alarm recorded in driver's data file.Customer complaint could not be replicated.Failure investigation for this complaint could not confirm the root cause of the reported issue as the complaint was not able to be replicated.No test failures or damage were identified that could have contributed to the complaint.Freedom driver functioned as designed.Patient was switched to a backup driver with no 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.

Event Description

The customer, a syncardia authorized distributor, reported a fault alarm on freedom driver while supporting a patient.The display showed asterisks instead of values for cardiac output and fill volume.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

• 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: 14951194
• MDR Text Key: 296010460
• Report Number: 3003761017-2022-00064
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• 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: 10/31/2023

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: Lay User/Patient
• 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: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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: 55 MO
• Patient Sex: Male