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

Catalog Number 1407DE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

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.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.Additionally there is 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.A supplemental report will be submitted when the manufacturer's investigation has been completed.

Event Description

It was reported by the site that there was damaged noticed on the display of the controller, where not all the letters were showing on the display.The controller was electively exchanged.No additional information provided.Investigation is ongoing.

Manufacturer Narrative

(b)(4) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed.Analysis of the device could not be performed since the device was not returned for evaluation.Analysis could not be performed as the device was not returned heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Manufacturer Narrative

After further review of additional information received sections have been updated accordingly.Correction: the reported event of a faulty display on the returned controller, (b)(4), could not be confirmed.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The unit was sent to the supplier, where analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The liquid crystal display (lcd) performed as expected.Additionally, the leds were all functional.As a result, the reported event could not be confirmed; the device passed visual and functional testing.No failure detected, the reported event could not be duplicated at the bench level.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 60 avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• Manufacturer Contact: tatyana chorny ; 14400 nw 60 avenue; miami lakes, FL 33014-3105 ; 3053641476
• MDR Report Key: 5480290
• MDR Text Key: 39688367
• Report Number: 3007042319-2016-01007
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2016

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: 06/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/30/2016; 11/16/2016
• 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
• Patient Sequence Number: 1