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

Catalog Number 1407DE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

The instructions for use (ifu) and patient manual include a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.This device is used for treatment not diagnosis.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported by a head perfusionist that the patient's controller had failed during visual inspection as part of smr-upgrade: preliminary test procedure p.1.2 no scratches on display.There are scratches that have impact on readability of the display.

Manufacturer Narrative

The reported event (scratched lcd display) was confirmed during the controller visual inspection.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event was confirmed via visual inspection.The controller front panel lcd display window was found scratched.The most likely root cause for the scratches on the lcd display might be attributed to the handling of the controller.Functionality of the unit was not affected by the scratched lcd display.Analysis of the device revealed that the device failed to meet specifications; the device passed functional testing but failed visual examination as there was a displaced o-ring on power port 1.An internal inspection of the controller reveal a foreign material; however, this observation was not related to the reported event and did not affect the device's functionality.Additionally, it was noted during visual inspection that the controller port 1 o-ring gasket was displaced.However, this condition had no effect on the normal functionality of the unit as the controller port 1 connector remains tight to the controller housing.The controller functionality was tested and the system testing did not indicate any abnormal operation of the controller.A possible root cause of the loose connector may be attributed to a shift in the manufacturing process.The most likely root cause for the scratches on the lcd display might be attributed to the handling of the controller.The manufacturer has opened an internal investigation to evaluate the loose connectors.Heartware will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM, BATTERY
• 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: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5535827
• MDR Text Key: 41552440
• Report Number: 3007042319-2016-01412
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

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: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FSCA APRIL 2016
• Patient Sequence Number: 1