MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; CIRCULATORY ASSIST DEVICE

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2014

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the patient was walking back form the atrium window area in the hospital when the fault alarm sounded.The patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a fault alarm, the freedom driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

The secondary motor cam follower, by default, is set to the bottom dead center (bdc) position during the manufacturing process.However, upon inspection at syncardia, the secondary motor was found to be moved out of the bdc position.The physical damage found on the unit and the position of the secondary motor indicated that the likely root cause of the customer-reported fault alarm was an impact shock to the driver.Despite the damage observed on the driver, the driver passed all performance testing requirements with no anomalies or alarms.In addition, the secondary motor was tested to confirm proper operation of all electronics, and the driver met all pressure test acceptance criteria at normotensive and hypertensive settings.The driver performed as intended and there was no evidence of a device malfunction.Review of the eeprom data and failure investigation testing indicated that there was likely an impact shock to the driver, causing the secondary cam follower to move out of bdc position during operation.The driver switched from the primary motor to the secondary motor, resulting in the 'secondary motor voltage too high' alarm.The motor/gearbox assemblies and print circuit assembly (pca) were replaced as a precautionary measure and the driver passed all final performance testing.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining functions.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

Event Description

The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed no abnormalities.Visual inspection of the driver's internal components revealed that the secondary motor was in the top dead center (tdc) position, indicating operation of the secondary motor circuit.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esq, vp ; 1992 e. silverlake rd.; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4380595
• MDR Text Key: 5240525
• Report Number: 3003761017-2014-00320
• Device Sequence Number: 1
• Product Code: LOZ
• 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,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• 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?: Yes
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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: 50 YR