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

Catalog Number 595000-001

Device Problems Computer Software Problem (1112); Nonstandard Device (1420)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a pt.The customer also reported that the reason for the fault alarm was "unclear".The pt subsequently went to the hospital and switched to a companion 2 driver.There was no reported adverse pt impact.This alleged failure mode poses a low risk to the pt because although the freedom driver exhibited a fault alarm, the driver continued to perform its life-sustaining functions.The freedom driver will be returned to syncardia for eval.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient.The customer also reported that the reason for the fault alarm was "unclear." the patient subsequently went to the hospital and switched to a companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.During incoming investigation testing, the driver met all performance testing, which included normotensive and hypertensive settings, with no anomalies or alarms.The customer-reported fault alarm could not be reproduced during incoming investigation testing.Review of the electronic data revealed two permanent faults: secondary motor voltage too high and cardiac output too low for long enough to be permanent time-out.The secondary motor voltage too high was produced during functional testing as part of routine service/manufacturing for the driver.The cardiac output too low for long enough to be permanent time-out fault was likely the alarm that the customer experienced, which could be caused from kinking of the drivelines or patient hypertension or hypervolemia.The driver performed as intended, and there was no evidence of a device malfunction.The customer-reported issue could not be reproduced.Results from failure investigation testing indicate that the customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The freedom driver was serviced and passed all functional and performance testing before being placed into finished goods.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4589771
• MDR Text Key: 16992635
• Report Number: 3003761017-2015-00081
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 595000-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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: 66 YR