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

Catalog Number 1407DE

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

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 hvad controller is a microprocessor unit that controls and manages the heartware system operation.It sends power and operating signals to the blood pump and collects information from the pump.The instructions for use (ifu) and patient manual instructs users to return any damaged components to heartware.Inability to read the display associated with an alarm may result in no action or the wrong or inappropriate action taken in response to critical alarms.This may result in pump stoppage which has the potential harm for serious injury or death due to hypoperfusion, thrombus and associated sequelae including death.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report was received that a controller had a faulty display with abnormal characters seen.The site reported that the controller had not been dropped and did not look like it had been dropped.The device was exchanged with no reported patient injury and no further issues.

Manufacturer Narrative

After further review of additional information received date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes and additional mfr narrative have been updated accordingly.The controller was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.The reported event could not be confirmed.Analysis of the device revealed that the device met specifications; the device passed visual examination and functional testing.The controller was allowed to run for an extended period of time.The led on each power ports, the characters and back light were present on the display.There was no evidence of the display becoming faulty.The results revealed that the controller was able to display all characters properly.No failure detected; the controller was able to display all characters properly.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, PRODUCT CODE, PRODUCT CODE
• 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: 5906451
• MDR Text Key: 53096147
• Report Number: 3007042319-2016-03022
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: LU
• 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
• Report Date: 08/02/2016

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: 02/29/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• 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
• Patient Weight: 76