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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 Alarm System (1012); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 02/29/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2016, the customer reported that the freedom driver exhibited an irreversible fault alarm while supporting a patient.The customer also reported that the alarm persisted after the onboard batteries were exchanged.The customer also reported that the onboard batteries had 2 bars illuminated on the battery gauge during the reported fault alarm.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.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
On (b)(6) 2016, the customer reported that the freedom driver exhibited an irreversible fault alarm while supporting a patient.The customer also reported that the alarm persisted after the onboard batteries were exchanged.The customer also reported that the onboard batteries had 2 bars illuminated on the battery gauge during the reported fault alarm.The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver's external and internal components revealed no abnormalities.The driver in "as received" condition passed all required functional testing requirements, which included normotensive and hypertensive settings, with no anomalies or alarms.The electronic data alarm history revealed a "speaker 1 voltage too high when on" fault code, which can occur during any of the following scenarios: during power cycling of the freedom driver, during onboard battery exchange while operating the driver only on battery power, and/or if an onboard battery is not fully latched in place and intermittent communications can result in a fault alarm.The driver performed as intended during investigation testing, and there was no evidence of a device malfunction during investigation testing.The customer experience was not reproduced.Based on the customer experience, the likely root cause of the reported alarm was the result of operating the freedom driver with low charged onboard batteries.Per syncardia's freedom driver system guidebook for patients and caregivers - us, section 7.2, battery alarms must be addressed immediately by replacing low charged onboard batteries with fully charged onboard batteries, by connecting the freedom driver to external power to charge the onboard batteries, or by reinserting the incorrectly installed onboard batteries until they are locked in place.A battery alarm will turn into a fault alarm if it is not addressed and one or both onboard batteries' charge levels drop below 30%.Despite the customer-reported fault alarm, risk to the patient was low because the driver continued to perform its life-sustaining functions.The driver was serviced.Based on days of use, the speaker printed circuit board assembly (pcba), motor controller pcba, and motor/gearbox assemblies were replaced 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 Key5518402
MDR Text Key41159243
Report Number3003761017-2016-00096
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 faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2016
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 Manufacturer03/17/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2011
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 Age66 YR
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