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 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 (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.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 from the site that there was a date/time loss after each controller restart during upgrade.An elective controller exchange was performed and it was noted that there were no effect on patient.No additional information available.

Manufacturer Narrative

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.According to the instructions for use (ifu), users are instructed to input the current date and time when setting up both the primary and backup controllers.According to the ifu, controllers are expected to function for at least one year.The controller's internal, non-replaceable, rechargeable battery is used to power an audible "no power" alarm when both power sources are disconnected.The instructions for use (ifu) warns users that a controller with a blank display or no audible alarms should be replaced.The controller (b)(4) 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 was confirmed via functional testing.Analysis of the device revealed that the device failed to meet specifications.The device passed visual examination but failed functional testing due to a defective real time clock battery located on the main board printed circuit assembly (pca).This battery had 0 volts of charge and corrosion on the outside.These observations will result in a continuous reset of the real time clock.It should be noted that this controller was built on (b)(6) 2012 and has been in service since.The controller was upgraded to smr.A dhr review of the manufacturing documentation confirmed that (b)(4) met all requirements for release.Additionally, during functional testing, the controller failed to sound the alarm when both power sources were disconnected.Supplemental testing showed a defective nickel-metal hydride battery (nimh) located on the power board printed circuit assembly, with cell #1 being unable to charge and showing 0 volts; this internal battery also had corrosion on the outside.This anomaly is not related to the reported event and is currently being investigated by the manufacturer.As a result of these conditions, the controller was deemed to be out of specifications.The most likely root cause for the real time clock error is a defective internal battery (nickel-metal hydride battery or nimh).Note: this controller was upgraded to smr.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
• 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: nathalie nunez ; 14400 nw 60 avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5762357
• MDR Text Key: 48569863
• Report Number: 3007042319-2016-02447
• 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: 06/06/2016

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: 11/30/2013
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1731-2015
• Patient Sequence Number: 1