MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1403US

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings, including transportation.The instructions for use and patient manual include a warning to keep a spare back up controller available at all times and outlines that if there is a controller failure, the controller should be switched to the back-up controller.The steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.The "controller failed" alarm indicates a potential controller failure; the controller should be exchanged with the back-up controller.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.Device has not been received.

Event Description

It was reported that the patient received a "controller failed" alarm at home shortly after being discharged.The patient contacted the vad coordinator after successfully exchanging the primary controller to the back-up; however, but refused to come to the hospital for further assessment as instructed.A new controller was shipped via federal express and a follow up appointment scheduled for the following week.There were no further reports of alarms.

Manufacturer Narrative

One controller ((b)(4)) was not returned for evaluation.Analysis of the device could not be performed since the device was not returned for evaluation after several attempts to obtain it were made.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Log file analysis revealed several low flow alarms, however, none were near the reported event date.No controller fault or controller failed alarms were logged in the alarm file.Based on the available information, the reported event could not be confirmed.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: natalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6021658
• MDR Text Key: 57155072
• Report Number: 3007042319-2016-03592
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 1403US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1