MAUDE Adverse Event Report: SYNCARDIA SYSTEM INC. SYNCARDIA FREEDOM DRIVER; SYNCARDIA TOTAL ARTIFICIAL HEART SYSTEM INC.

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  Injury  

Event Description

Received review from manufacturer 09/2016.Patient experienced fault alarm while on driver #4663 for b/p 138 systolic, b/p was stable at 100-120 - switched to driver 46/7.Number 4663 - returned to syncardia for evaluation of issue/alarm."fault history revealed code 19 bottom pressure too low this condition is known to be associated with degraded performance of u22 pressure sensor component on the main pcba" (circuit board).

• Brand Name: SYNCARDIA FREEDOM DRIVER
• Type of Device: SYNCARDIA TOTAL ARTIFICIAL HEART SYSTEM INC.
• Manufacturer (Section D): SYNCARDIA SYSTEM INC.; 1992 e. silverlake rd.; tucson AZ 85713
• MDR Report Key: 6000952
• MDR Text Key: 56556434
• Report Number: 6000952
• Device Sequence Number: 1
• Product Code: LOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2016
• Distributor Facility Aware Date: 08/09/2016
• Device Age: NA
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 77