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

Model Number 595000-001

Device Problems Output Problem (3005); Audible Prompt/Feedback Problem (4020)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be evaluated by syncardia.The results will be provided in a follow-up mdr.(b)(4).

Event Description

While performing routine servicing, a syncardia technician reported that the freedom driver exhibited a fault alarm.

Manufacturer Narrative

Device history record (dhr) 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.One was produced during data file extractions and the other indicates cardiac output was too low for long enough to cause a permanent time-out.Visual inspection of external components found a scratch on the display cover window.Visual inspection of internal components found front housing anchor bosses cracked and the top left anchor boss was pulled out.Scuff marks were also found on the piston cylinder assemble and the main board component, where they align, as well as either side of the main board motor cut-out.A foreign substance was also noted on the main board near several components.Freedom driver passed all areas of functional testing for acceptance at incoming inspection.Prior complaint investigations have found output issues to be due to a failure in the flow sensor cable.A "pull and wiggling" test was performed by operating the driver at normal settings and pulling/wiggling the cable after about 15 minutes of operation.Asterisks were produced for cardiac output and fill volume and a fault alarm annunciated, replicating the initial complaint.Further investigation identified a that one of the cable's wires was broken from the pin on the connector end.Failure investigation for this complaint confirmed the reported issue.The customer complaint was replicated during testing; the root cause of the reported out of specification output values was determined to be a broken wire on the airflow sensor cable.Failure investigation identified no other test failures or damage that could have contributed to the complaint.Damage found outside of the airflow sensor cable was cosmetic only.Device was not in patient use at the time of complaint.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

While performing routine servicing, a syncardia technician reported that the freedom driver exhibited a fault alarm.

• 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: 12917389
• MDR Text Key: 282289366
• Report Number: 3003761017-2021-00226
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003121
• UDI-Public: (01)00858000003121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• 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