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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM DRIVER; EXTERNAL PNEUMATIC DRIVER Back to Search Results
Catalog Number 595000-001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Dyspnea (1816); Dizziness (2194); Discomfort (2330)
Event Date 09/24/2016
Event Type  Injury  
Manufacturer Narrative
The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
 
Event Description
The customer reported that, while supported by the freedom driver, the patient called ems because he had difficulty breathing, felt lightheaded and could not "catch his breath".The patient reported he had to lie down on the floor to get relief.The customer also reported that the patient said the freedom driver never "felt right".The customer also reported that the freedom driver did not exhibit any alarms.The customer also reported that when the patient arrived at the hospital, he was subsequently switched to his backup freedom driver with no reported adverse patient impact.The customer also reported that the patient stated he felt much better after the switch.
 
Manufacturer Narrative
The freedom driver was returned to syncardia for evaluation.The driver in "as received " condition passed all functional test requirements, which included cardiac output (co), right atrial pressure (rap), aortic pressure (aop), pulmonary arterial pressure (pap) and left atrial pressure (lap) performance metrics associated with normotensive and hypertensive settings, with no anomalies or alarms.In addition, the driver was tested for an additional 48 hours at normotensive settings and performed as intended with no anomalies or alarms.The root cause of the customer-reported issue could not be determined.There was no evidence of a device malfunction and the driver performed as intended during functional testing.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.(b)(4).
 
Event Description
The customer reported that, while supported by the freedom driver, the patient called ems because he had difficulty breathing, felt lightheaded and could not "catch his breath".The patient reported he had to lie down on the floor to get relief.The customer also reported that the patient said the freedom driver never "felt right".The customer also reported that the freedom driver did not exhibit any alarms.The customer also reported that when the patient arrived at the hospital, he was subsequently switched to his backup freedom driver with no reported adverse patient impact.The customer also reported that the patient stated he felt much better after the switch.
 
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Brand Name
SYNCARDIA FREEDOM DRIVER
Type of Device
EXTERNAL PNEUMATIC DRIVER
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6024882
MDR Text Key57251172
Report Number3003761017-2016-00343
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 09/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? Yes
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 Manufacturer10/17/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2012
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 Outcome(s) Required Intervention;
Patient Age62 YR
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