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

Model Number 595000-001

Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906); Audible Prompt/Feedback Problem (4020)

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

Event Date 03/04/2021

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.(b)(4) initial.

Event Description

The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting the patient.The patient stated he bore down and the alarm began.Additionally, the driver beat rate changed from 137 bpm to 127 bpm.There was no reported adverse patient impact.The customer also reported that the patient was subsequently switched to a backup driver.

Manufacturer Narrative

Two new permanent alarms recorded in the driver's alarm history.This alarm is produced during functional testing after manufacturing or service, and as a result of secondary motor engagement.Visual inspection of external components found no evidence of damage or abnormalities.Visual inspection of internal components found the secondary motor out of default position, scuff marks on the main pcb and primary motor bezel, cracked housing bosses on the front housing cover, and a melt mark on the ribbon cable, speaker to lcd.The driver passed all incoming functional testing.Additional observation testing and a valsalva maneuver test was performed simulating patient conditions resulting from heavy coughing or 'bearing down' as reported by the patient.Driver performed as intended, annunciating an alarm due to low cardiac output and recovering after a few seconds.No permanent alarms were produced as a result of the tests.Testing found no evidence of a device malfunction.The customer reported fault alarm was confirmed through alarm history data review, which found two new permanent fault alarms recorded in the driver's alarm history.The fault code recorded occurs as a result of secondary motor engagement, which was confirmed during inspection of the internal components.This is further evidenced by the reported drop in beat rate from 137 bpm to 127 bpm.The beat rate resets to the default rate of 125 +/- 5 bpm when switching to the secondary motor.The driver is designed to alarm when it switches to operation on the secondary motor to alert the user to exchange the driver.Additional observation and valsalva maneuver testing did not replicate the issue.The driver the root cause of the permanent fault alarm was secondary motor engagement.This is not a device malfunction.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.(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: 11477569
• MDR Text Key: 245517493
• Report Number: 3003761017-2021-00039
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 03/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2018
• 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: 32 YR
• Patient Sex: Male