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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 03/19/2015
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 switched out the freedom onboard batteries, but the alarm did not resolve.The customer also reported that the patient did not "feel right." the lowest fill volume the patient noticed was 36 milliliters (ml).The patient was subsequently switched to the backup freedom driver.This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited intermittent fault alarms, 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
(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 patient switched out the freedom onboard batteries, but the alarm did not resolve.The customer also reported that the patient did not "feel right." the lowest fill volume the patient noticed was 36 milliliters (ml).The patient was subsequently switched to the backup freedom driver.There was no reported patient impact.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 foreign object debris on the exhaust fan, fan cover, pca and motor/gearbox assemblies.During investigation, operation of the exhaust fan, piston and cylinder assembly (pca) and motor/gearbox assemblies did not result in any fault alarms.The driver in "as received" condition passed all test acceptance criteria, which included normotensive and hypertensive settings, with no anomalies or alarms.The driver was tested for an additional 24 hours at normotensive settings, and elevated left atrial pressure (laps) were observed.The pca was replaced with a pca that previously met test performance requirements, and the driver was tested for an additional 24 hours.The driver functioned as intended during the second 24-hour observation run.The customer-reported fault alarm was not reproduced during incoming investigation testing.Review of the electronic data did not reveal any new alarms that occurred while the driver was supporting the patient.Only permanent fault alarms are recorded in the driver's alarm history.Intermittent, recoverable and battery alarms are not recorded in the electronic data.It is likely that the customer experienced an intermittent and/or recoverable temperature alarm, with a root cause attributable to the foreign object debris found during the visual inspection of the internal components.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining-functions.Based on the driver's days of use, the main printed circuit board assembly (pcba), speaker pcba, pca, motor/gearbox assemblies, and motor controller pcbas, were replaced.The driver was serviced 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.
 
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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
ce 2700
tucson, AZ 85713
5205451234
MDR Report Key4669406
MDR Text Key5732125
Report Number3003761017-2015-00113
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
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 03/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age29 YR
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