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

Catalog Number 1407DE

Device Problems Image Display Error/Artifact (1304); Protective Measures Problem (3015)

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

Event Date 06/06/2016

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 and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damage.Additionally, a reference guide for both visual and tone alarms including potential causes and actions to take and there is a warning to keep spare, fully charged batteries and back up controller available at all times.It also provides information about proper care of the system and what to do in case of an emergency.Always wait until the "ready" turns on to disconnect the battery from the battery charger.Heartware will submit a supplemental report if new facts arises which materially alters information submitted in a previous mdr report.

Event Description

It was reported that suddenly the controller displayed 'controller fault alarm' and displayed pump parameters on screen.  the controller was exchanged.No consequence to patient.  no additional information required.

Manufacturer Narrative

The reported event of multiple controller fault alarms was confirmed on the returned controller, (b)(4).Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Log file analysis revealed multiple controller fault alarms.The controller fault alarms indicated that the speed was over the maximum range.Log analysis revealed that current and voltage parameters were outside of normal operating range.Analysis of the controller revealed that the device passed visual examination but failed functional testing.The controller powered up but was unable to run a motor fixture.Supplemental testing revealed a damaged transistor on the controller's power board.The transistor is located in the circuit that drives the pump.As a result, the faulty transistor affected the ability of the controller to power a pump.Additionally, the damaged transistor caused an increase in current consumption, confirming the reported event that all values were maxed out.Replacing the damaged transistor returned the controller to full functionality.A supplier investigation is currently evaluating transistors that may be contributing to controller fault alarms.The most likely root cause of the reported event can be attributed to a damaged transistor on the controller's power board.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: 6182184
• MDR Text Key: 62711057
• Report Number: 3007042319-2016-04455
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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