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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); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) initial.
 
Event Description
The customer reported that the freedom driver exhibited a battery alarm.The customer also reported that the patient replaced the onboard batteries with 2 fully-charged onboard batteries and the freedom driver had a 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
The customer reported that the freedom driver exhibited a battery alarm.The customer also reported that the patient replaced the onboard batteries with 2 fully-charged onboard batteries and the freedom driver had a 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.Review of the electronic data revealed a fault code that can be caused during onboard battery exchange while operating the freedom driver only on battery power, or if an onboard battery is not fully latched in place where intermittent communication errors can result in a fault alarm.The driver passed all testing requirements, which included nominal normotensive and hypertensive settings with no anomalies or alarms.The customer experience was not duplicated and the root cause could not be determined.The driver performed as intended, and there was no evidence of a device malfunction.The onboard batteries utilized by the customer were not returned.Therefore, they could not be evaluated and included in this report.The driver was serviced and passed all final performance testing before placed into finished goods.The customer-reported 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.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 Key5738618
MDR Text Key48719738
Report Number3003761017-2016-00239
Device Sequence Number1
Product Code LOZ
UDI-Device Identifier00858000003121
UDI-Public(01)00858000003121
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 06/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer06/17/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/10/2016
Initial Date FDA Received06/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2012
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 Age65 YR
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