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 06/25/2022

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 that the freedom driver exhibited a fault alarm 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

Inspection of the driver's alarm history found one new alarm was recorded in the driver alarm data history file.This fault code can occur if a change in lcd supply pre-regulatory voltage is detected.Visual inspection of external components found cosmetic damage to the latch housing of the external power to main board connector cable, which does not impact functionality, and a missing shoulder strap loop (plastic), which had been replaced with a metal key ring.Visual inspection of internal components found the boss which holds the hose clamp in place had been pulled loose.Damage observed is indicative of rough handling.Driver passed incoming functional testing.Extended observation testing was performed and testing determined the driver was operating as intended; no alarms occurred during testing.During failure investigation testing, the customer-reported issue was not reproduced.Visual inspection found multiple instances of cosmetic damage that would indicate the driver sustained rough handling.The fault code recorded in the driver's alarm history could have been caused by a voltage fluctuation in the external power to main pcb connector cable, as a result of vibration from rough handling, causing the driver to alarm.The failure investigation confirmed the reported fault alarm based upon the permanent fault code recorded in the driver's alarm history data file.However, functional and observation run testing could not replicate the fault alarm.Changes in voltage as a result of damage sustained by the external power to main board cable connector is the most likely root cause of the fault alarm based upon the fault code found in the alarm history file.Damage observed to both internal and external components during visual inspection is indicative of rough handling.The customer did not provide information related to driver condition beyond the fault alarm.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: 14987173
• MDR Text Key: 295876596
• Report Number: 3003761017-2022-00068
• Device Sequence Number: 1
• Product Code: LOZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2019
• 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: 29 YR
• Patient Sex: Male