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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM
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SYNCARDIA SYSTEMS, LLC SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM Back to Search Results
Model Number 500101
Device Problem Insufficient Information (3190)
Patient Problems Pulmonary Embolism (1498); Loss of consciousness (2418)
Event Date 09/16/2016
Event Type  Injury  
Event Description
He was in physical therapy in the afternoon and while lying on his back with his knees up, the therapist was massaging his hip area.He "blacked out" momentarily and at that time the freedom driver had a temporary fault alarm that resolved spontaneously.Driving home from therapy, he didn't feel right and felt a fluttering in his chest.The device had three more temporary fault alarms.The family thought these things were caused by impending freedom driver failure, so they changed from the freedom drive.Back to normal.Ventricular assist device (vad) coordinator recommended the patient come to emergency department for admit.Vad team will meet him.Keep total artificial heart (tah) within set parameters set specific for the patient; maintain therapeutic coags; ct angio showed pulmonary embolus.Syncardia consulted regarding international experience of treatment of pulmonary embolism in tah patients.
 
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Brand Name
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM
Type of Device
ARTIFICIAL HEART
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e silverlake rd
tucson AZ 85713
MDR Report Key7107916
MDR Text Key94516504
Report Number7107916
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Model Number500101
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2017
Event Location Hospital
Date Report to Manufacturer12/06/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS; CVVHD (DIALYSIS); DIALYSIS
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age31 YR
Patient Weight84
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