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

Catalog Number 595000-001

Device Problems False Alarm (1013); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

The customer reported that the freedom driver exhibited a fault alarm while supporting a patient at home.The customer also reported that the patient switched to the backup freedom driver without any patient impact.This alleged failure mode poses a low risk to the patient because it does not prevent the freedom driver from performing 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 at home.The customer also reported that the patient switched to the backup freedom driver without any patient impact.Freedom driver s/n (b)(4) was returned to syncardia for evaluation.Visual inspection of the exterior of the driver revealed no abnormalities.Visual inspection of the interior of the driver revealed the secondary motor was in the top dead center (tdc) position, which indicated operation of the secondary motor circuit.The secondary motor is set to bottom dead center (bdc) position during driver servicing/manufacturing.However, during incoming failure investigation inspection, the secondary motor was observed to be out of the bdc position.The root cause is unknown, but testing determined that these results are consistent with an impact shock, which is also evidenced by the secondary cam follower moving from the bdc to the tdc position during operation.The driver switched from the primary motor to the secondary motor, which resulted in the "secondary motor voltage too high" alarm.Despite the secondary motor in the tdc position, the driver met all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or alarms.In addition, the secondary motor was tested to confirm proper operation of all electronics.The driver performed as intended, and there was no evidence of a device malfunction.As a precautionary measure, the motor/gearbox assembly was replaced, the driver was serviced and passed all final performance testing.The customer reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.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 (Section G): 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: 4939776
• MDR Text Key: 22592935
• Report Number: 3003761017-2015-00228
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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: 42 YR