MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC CARDIOWEST TAH-T; ARTIFICAL HEART

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2017

Event Type  malfunction  

Event Description

Critical alarm from primary total artificial heart (tah) driver prompted the switch to the backup driver.Critical alarms occurred in the backup driver shortly after the switch prompting placing patient on c2 driver.Pt has prior history of full-filling, however he had been dialyzed successfully the day prior.C2 confirmed full-filling.Patient was asymptomatic during alarms and driver exchanges.The tah never stopped working.

• Brand Name: CARDIOWEST TAH-T
• Type of Device: ARTIFICAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC; 1992 east silverlake rd.; tucson AZ 85713
• MDR Report Key: 7250781
• MDR Text Key: 99329379
• Report Number: 7250781
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 47 YR
• Patient Weight: 106