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

Model Number 595000-001

Device Problems Image Display Error/Artifact (1304); Loose or Intermittent Connection (1371); No Apparent Adverse Event (3189); Audible Prompt/Feedback Problem (4020)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The customer, a (b)(6) reported that the freedom driver exhibited a fault alarm and displayed asterisks instead of numbers after the patient coughed.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup freedom driver.

Manufacturer Narrative

Freedom driver s/n (b)(6) passed all testing requirements defined per (b)(4), freedom driver system final test and acceptance procedure during incoming inspection.Visual inspection of driver exterior found no damage or abnormalities.Visual inspection of driver interior identified particulate debris on top of the piston cylinder assembly (pca) and primary and secondary motors.The secondary motor was also found out of default position indicating secondary motor engagement.Alarm history data review found three new alarms recorded in the driver; two "2d" fault code alarms which occur as a result of secondary motor engagement and one "4a" fault code alarm, which can occur when the driver is left running while disconnected from a patient or patient simulator.Testing was performed to replicate the asterisks displayed for fill volume and cardiac output and permanent alarm.Manual manipulation of the airflow sensor cable produced fill volume and cardiac output display reading fluctuations as well as an alarm.An extended observation run of 48 hours did not produce any additional alarms or display errors.The root cause of the permanent fault alarm is most likely attributed to the patient condition, i.E., coughing.Excessive coughing can cause a sudden increase in the pulmonary pressure which will cause a momentary drop in cardiac output and can cause the driver to switch to the secondary motor.Since evidence of secondary motor engagement was found during incoming inspection, this is the most likely cause of the permanent fault alarm.The root cause of the asterisks displayed for cardiac output and fill volume as reported by the customer and display reading fluctuations observed during testing is most likely an intermittent connection in the cable that connects the airflow sensor to the main pcba.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.Ce (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: 10286406
• MDR Text Key: 201866047
• Report Number: 3003761017-2020-00154
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 595000-001
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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: 66 YR
• Patient Sex: Male