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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 500101-001
Device Problems Unstable (1667); Device Operates Differently Than Expected (2913)
Patient Problems Pulmonary Embolism (1498); Loss of consciousness (2418); Palpitations (2467)
Event Date 09/16/2016
Event Type  Injury  
Event Description
Pt admitted to ccu (cardiac care unit) following episode of loc (loss of consciousness) and palpitations with ct angio chest.Ct was significant for acute pe (pulmonary embolism).There was concern for a possible thrombus causing tah (total artificial heart) alarms.Driver changed and so far everything ok.We have ordered a second backup driver to be delivered today to have at bedside.Recurrent device alarms secondary to pe required multiple visits to the bedside for active titration of vasoactive drips and device interrogation with high potential for hemodynamic instability.
 
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Brand Name
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART SYSTEM
Type of Device
ARTIFICIAL HEART
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 east silverlake rd.
tucson AZ 85713
MDR Report Key7236942
MDR Text Key98866067
Report Number7236942
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 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Model Number500101-001
Other Device ID Number500101
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/26/2018
Event Location Hospital
Date Report to Manufacturer01/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
DIALYSIS; OTHER, HEPARIN AND NITROUS OXIDE AND CVVHD; TOTAL ARTIFICIAL HEART AND DIALYSIS FOR ESRD.
Patient Outcome(s) Life Threatening;
Patient Age31 YR
Patient Weight84
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