MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC CARDIOWEST TAH-T; ARTIFICIAL HEART

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Event Description

Patient with total artificial heart (tah) therapy for 8 months presents with more critical tah alarms requiring driver change.(patient had previously changed driver 2 days prior).Patient was placed on c2 where full-filling was confirmed.Patient was asymptomatic.Driver change was uncomplicated.The tah driver never stopped running despite alarms.

• Brand Name: CARDIOWEST TAH-T
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 east silverlake rd.; tucson AZ 85713
• MDR Report Key: 7250766
• MDR Text Key: 99328885
• Report Number: 7250766
• 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: 05/01/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Device Age: 8 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