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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 Problems Device Alarm System (1012); Component Falling (1105); Device Emits Odor (1425)
Patient Problem Loss of consciousness (2418)
Event Date 09/19/2016
Event Type  Injury  
Manufacturer Narrative
The patient did not change out the driver after the drop, as instructed by the ifu and the hands-on training by the hospital.Freedom driver system guidebook for patients and caregivers section 4 warnings states "if the freedom driver or any of the accessories are dropped, bring them to your hospital for replacement." the freedom driver has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: (1) freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00324 and (2) freedom power adaptor s/n (b)(4) mfr report # 3003761017-2016-00340).The customer reported that the wife of the patient awoke to no sounds coming from his freedom driver.The wife reported that there were no alarms, the freedom driver was not running and the patient was not responsive.The customer also reported that the patient was switched to his backup freedom driver and revived.The customer also reported that the patient came to the hospital, was given new freedom drivers and was admitted for observation.The customer also reported that the patient was subsequently released and returned to his home.On (b)(6) 2016 the customer reported the following additional information: the patient's wife removed the power adaptor from freedom driver s/n (b)(4) after the exchange to the patient's backup freedom driver.She reported that she removed it because of a 'hot' smell.The patient's wife also reported that the patient dropped the freedom driver about 1 week before the event.The freedom driver fell 6 inches on to the floor.
 
Manufacturer Narrative
The patient did not change out the driver after the drop, as instructed by the ifu and the hands-on training by the hospital.Freedom driver system guidebook for patients and caregivers section 4 warnings states "if the freedom driver or any of the accessories are dropped, bring them to your hospital for replacement." the freedom driver was returned to syncardia for evaluation.Visual inspection of the external components of the driver revealed a missing power adaptor.Visual inspection of the internal components of the driver revealed discoloration of the solder joint at pin 1 of j8 connector on the main printed circuit board assembly (pcba).An electrical burning odor was also noted upon removal of the rear housing.The as received functional test could not be performed as a result of the malfunction of the main pcba.However, when the driver was tested with a clinically equivalent main pcba, power adaptor, and power supply installed, the driver passed all pressure test requirements associated with normotensive and hypertensive settings with no issues.The customer-reported driver stop was reproduced during investigation testing.The root cause of the stoppage was identified as a malfunction of the main pcba only for the 5000 series freedom driver.On november 3, 2016, syncardia notified the fda in an 806 report of a voluntary field action whereby all 5000 series freedom drivers were returned to syncardia.(b)(4).
 
Event Description
The reported issues involve the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00324) and freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2016-00340).The customer reported that the wife of the patient awoke to no sounds coming from his freedom driver.The wife reported that there were no alarms, the freedom driver was not running and the patient was not responsive.The customer also reported that the patient was switched to his backup freedom driver and revived.The customer also reported that the patient came to the hospital, was given new freedom drivers and was admitted for observation.The customer also reported that the patient was subsequently released and returned to his home.On 09/21/2016 the customer reported the following additional information: the patient's wife removed the power adaptor from freedom driver s/n (b)(4) after the exchange to the patient's backup freedom driver.She reported that she removed it because of a 'hot' smell.The patient's wife also reported that the patient dropped the freedom driver about 1 week before the event.The freedom driver fell 6 inches on to the floor.
 
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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 Key6011777
MDR Text Key56829956
Report Number3003761017-2016-00324
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 Recall
Type of Report Initial,Followup
Report Date 09/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2016
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 Manufacturer09/20/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2016
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) Hospitalization; Required Intervention;
Patient Age56 YR
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