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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC CARDIOWEST TAH-T; ARTIFICIAL HEART
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SYNCARDIA SYSTEMS, INC CARDIOWEST TAH-T; ARTIFICIAL HEART Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Failure to Shut Off (2939)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2016
Event Type  malfunction  
Event Description
A total artificial heart (tah) patient for 4 months was recently discharged from hospital, and status post unplanned driver change 4 days prior for same, now presents with alarms on another driver.Tah driver did not stop running.Pt asymptomatic.Tah driver was changed by family member in the home with assist of hospital team via phone.No complications with driver change.Pt was admitted and placed on the syncardia c2 for additional hemodynamic information, and was found to be full-filling.Fluid removed via dialysis over several weeks, and patient was successfully returned to what is now his 3rd tah driver.
 
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Brand Name
CARDIOWEST TAH-T
Type of Device
ARTIFICIAL HEART
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC
1992 east silverlake rd.
tucson AZ 85713
MDR Report Key7250829
MDR Text Key99327075
Report Number7250829
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/31/2019
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2018
Device Age4 MO
Event Location Home
Date Report to Manufacturer02/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Age47 YR
Patient Weight250
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