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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); Failure of Device to Self-Test (2937); Noise, Audible (3273)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2015
Event Type  malfunction  
Event Description
The freedom driver was not supporting a patient.The customer reported that the freedom driver did not pass the system check.The customer also reported that when she inserted a fully charged freedom onboard battery into the driver, the driver immediately exhibited a fault alarm.This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.In addition, it would not prevent the driver from performing 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.
 
Event Description
The freedom driver was not supporting a patient.The customer reported that the freedom driver did not pass the system check.The customer also reported that when she inserted a fully charged freedom onboard battery into the driver, the driver immediately exhibited a fault alarm.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's exterior revealed no abnormalities.Visual inspection of the driver's internal components revealed that the secondary motor was in the top dead center (tdc) position, which indicated that the driver was operating on the secondary motor circuit.The secondary motor is set to bottom dead center (bdc) position per syncardia's freedom driver position sensor adjustment procedure, during driver servicing/manufacturing.The electronic record revealed a "secondary motor voltage too high" fault code, which is the alarm experienced by the customer.The source of this fault code was confirmed to be operation of the secondary motor by the observation of the secondary motor in the tdc position.The driver in "as received" condition passed all test requirements while operating on the primary motor with no anomalies or unintended alarms.The driver was also tested on the secondary motor and exhibited an alarm, as expected.Despite the fault alarm, the driver passed all pressure test requirements with no anomalies.Although the customer experience was not reproduced, the customer-reported fault alarm was induced as a result of operation of the secondary motor.Although there was a fault alarm, there was no evidence of a device malfunction.The secondary motor positioned out of bdc was likely a result of an impact shock to the driver.The customer-reported issue posed a low risk to a patient because the driver was not supporting a patient at the time of the customer experience.In addition, the driver would not have been prevented from performing its life-sustaining-functions.The driver was serviced, which included the replacement of the piston and cylinder assembly (pca) and motor/gearbox assemblies, as a precautionary measure, 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
tucson, AZ 85713
5205451234
MDR Report Key4669408
MDR Text Key5732527
Report Number3003761017-2015-00111
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
Type of Report Initial,Followup
Report Date 03/18/2015
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 Health Professional
Device Catalogue Number595000-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2016
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
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