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

Catalog Number 595000-001

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to (b)(6) for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a (b)(6) authorized distributor, reported that the freedom driver exhibited a fault alarm and the fill volume and cardiac output values were very low while supporting a patient.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 record (dhr) review confirmed that freedom driver s/n 5176 was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found one new alarm indicating secondary motor voltage too high.There was no evidence of secondary motor engagement, therefore, fault code was likely produced in house during data extraction.Visual inspection of external and internal components found no abnormalities.Freedom driver passed all sections of functional testing at incoming inspection.An additional 24-hour observation run was performed, resulting in the driver's cardiac output occasionally dropping out of specification.No alarms were produced.A known functional piston cylinder assembly was installed as a replacement part for testing purposes.Driver passed all sections of functional testing after a second 24-hour observation run.No alarms were produced, no abnormalities with cardiac output were observed, and driver functioned as intended.Complaint could not be replicated as reported, however, pca was determined to be faulty contributing to low output values.Failure investigation for this complaint confirmed the reported issue.Although the alarm could not be replicated during functional and observational testing, it was determined that the low output values were due to a faulty pca.Failure investigation identified no other test failures or damage that could have contributed to the complaint.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 that the freedom driver exhibited a fault alarm and the fill volume and cardiac output values were very low while supporting a patient.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: 14497574
• MDR Text Key: 292697496
• Report Number: 3003761017-2022-00051
• 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: 12/12/2023

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: 05/13/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• 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: 44 YR
• Patient Sex: Male