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

Catalog Number 595000-001

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while the patient was exchanging his freedom onboard batteries.The customer also reported that the fault alarm did not resolve when the patient attempted to connect the driver to two fully charged onboard batteries and the ac power supply.The customer also reported that the patient's device readings displayed the beat rate (br) of 131, fill volume (fv) 57.7, and cardiac output (co) of 6.2.During the reported fault alarm.The patient was subsequently switched to the backup freedom driver, where the device readings displayed the br of 131, fv 52.9, and co of 7.1.There was no reported adverse patient impact.The customer also reported that the patient's blood pressure (bp) at the time of the event was 110/70.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 follow-up mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the freedom driver exhibited a fault alarm while the patient was exchanging his freedom onboard batteries.The customer also reported that the fault alarm did not resolve when the patient attempted to connect the driver to two fully charged onboard batteries and the ac power supply.The customer also reported that the patient's device readings displayed the beat rate (br) of 131, fill volume (fv) 57.7, and cardiac output (co) of 6.2.During the reported fault alarm.The patient was subsequently switched to the backup freedom driver, where the device readings displayed the br of 131, fv 52.9, and co of 7.1.There was no reported adverse patient impact.The customer also reported that the patient's blood pressure (bp) at the time of the event was 110/70.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external components revealed a damaged rear housing.Visual inspection of the driver's internal components revealed broken top and bottom left pem nut bosses and fractured top and bottom right pem nut bosses on the front housing.Based on damaged observed during visual inspection, the driver was likely subjected to an impact shock.Despite the physical damage observed on the driver, the driver met all acceptance criteria of pressure test requirements associated with normotensive and hypertensive settings during incoming investigation testing.The customer-reported fault alarm was not functionally reproduced.No new alarms were recorded on the electronic data since the driver last left syncardia in august 2015.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent, recoverable and battery alarms are not recorded in the electronic data.In an attempt to reproduce the customer experience, an onboard battery insertion/extraction test was performed.The driver functioned as intended with no issues.The customer-reported fault alarm could not be reproduced.During investigation testing, there was no evidence of a device malfunction, and the driver performed as intended.The customer-reported fault alarm posed a low risk to the patient because the driver continued to perform its life-sustaining functions.The driver was serviced, which included the replacement of the front and rear housings.Additionally, as a precautionary measure, service included the replacement of the motor/gearbox assemblies and piston and cylinder assembly, 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: 5490653
• MDR Text Key: 40307829
• Report Number: 3003761017-2016-00076
• 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: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• 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: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2013
• 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: 54 YR