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

Catalog Number 595000-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dizziness (2194); No Consequences Or Impact To Patient (2199)

Event Date 12/04/2014

Event Type  malfunction  

Event Description

The customer reported that the patient advised that his freedom driver sounded like it was slowing down then resuming normal speed while supporting a patient.The customer also reported that the patient felt light-headed.The patient went to the hospital and 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 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

Visual inspection of the exterior of the driver revealed no abnormalities.Visual inspection of the interior revealed foreign object debris on the fan cover, exhaust fan and speaker printed circuit board assembly (pcba), which did not affect the functionality of the driver and was not related to the reported issue.Visual inspection of the driver's interior components also revealed that the potentiometer used to adjust the primary motor beat rate was a non-specified component.The foreign object debris was removed and the potentiometer was replaced with a specified potentiometer.The driver then passed all final performance testing.The presence of this component on this driver is not related to this complaint.The non-specified potentiometer is functionally equivalent to the specified potentiometer.Syncardia has initiated a corrective (capa) to address the non-specified potentiometer issue.The capa is in process.Syncardia has completed its eval of this driver and is closing this file.

Event Description

The freedom driver was returned to syncardia for evaluation.The driver passed all test requirements, which included nominal normotensive and hypertensive settings, with no anomalies, alarms or decrease in beat rate.In addition, the driver was tested for an additional 140 hour run observation and performed as intended.The reported inconsistent beat rate could not be duplicated, and there was no evidence of a device malfunction.The reported issue posed a low risk to the pt because it did not prevent the freedom driver from performing its life-sustaining functions.The patient switched to the backup driver without adverse impact.

Manufacturer Narrative

The non-specified potentiometer used to adjust the primary motor beat rate did not affect the functionality of the driver and is not related to the reported issue.The non specified potentiometer is functionally equivalent to the specified potentiometer.The foreign object debris was removed and the potentiometer was replaced with a specified potentiometer.The driver then passed all final performance testing.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake rd.; tucson AZ 85713
• Manufacturer Contact: carole marcot, esq., vp ; 5205451234
• MDR Report Key: 4368391
• MDR Text Key: 5289517
• Report Number: 3003761017-2014-00302
• 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,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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: 60 YR