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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); Device Displays Incorrect Message (2591)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reported that the freedom driver exhibited an irreversible fault alarm after the patient had a coughing episode.The customer also reported that the patient was subsequently switched to the backup companion 2 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 an irreversible fault alarm after the patient had a coughing episode.The customer also reported that the patient was subsequently switched to the backup companion 2 driver.There was no reported adverse patient impact.The freedom driver was returned to syncardia for evaluation.Visual inspection of the external and internal components revealed no abnormalities.The driver was tested and passed all pressure test requirements, which included cardiac output, right atrial pressure (rap), aortic pressure (aop), pulmonary arterial pressure (pap) and left atrial pressure (lap) performance metrics associated with nominal normotensive and hypertensive patient simulator settings.Review of the alarm history (eeprom) revealed a fault alarm code that is indicative of a potentially failing u22 pressure sensor on the main pcba (printed circuit board assembly) and is consistent with the alarm that the customer experienced.Further investigation of the main pcba confirmed that the root cause for the reported fault alarm was a failure of the pressure sensor (u22) on the main pcba.The driver was serviced, including replacement of the main pcba, and passed all final performance testing.Syncardia initiated a corrective action (capa) to prevent u22 failures, which is in the process of being implemented.This failure mode posed a low risk to the patient because it did not prevent the freedom driver from performing 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 Key5323170
MDR Text Key34931721
Report Number3003761017-2015-00430
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 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2015
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 Manufacturer01/13/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/02/2012
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 Age70 YR
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