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 09/04/2015

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 that when the patient was changing the battery, the controller had a red alarm with the word fault that appeared on the controller.Also, the battery is not charging any more on battery charger and has a loose connection.The battery and controller were exchanged.There was no impact to the patient.

Manufacturer Narrative

One controller and one battery were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.Analysis of the controller revealed that the devices met specifications; the controller passed visual and functional testing.The controller fault alarm could not be duplicated during bench testing, however, log file analysis confirmed the reported event.During the controller log analysis, a controller fault alarm was observed, indicating an issue with the internal data flash memory, affecting the controller's ability to read or write updated settings.As a result, the controller reverts to default parameters.Analysis of the battery revealed that the device failed to meet specifications; the device failed visual inspection due a damaged cable.During external visual inspection, the battery was found with a damaged cable (outer sheath broken with exposed wires near to the battery pack housing).This observation is not related to the event reported.Additionally the battery failed functional testing as a result of multiple safety flags enabled, rendering the battery inoperable.The flags were the result of a communication failure to the integrated circuit responsible for providing cell voltages to the main integrated circuit.This condition confirmed the reported event (not charging) associated with the battery.Log file analysis also revealed multiple premature power switching events involving (b)(4).The premature switching events were most likely caused by a communication error between the controller and batteries.Heartware has opened an internal investigation, to investigate the root cause of communication errors between controller and battery.The most likely root cause of the reported "fault" alarm can be attributed to a data flash failure of the controller.The most likely root cause of the battery not charging can be attributed to an internal battery communication failure, causing the battery to trigger multiple flags and rending the battery inoperable.Additional system component being reported for this event: battery: (b)(4) - expiration date: 03-31-20215 manufacturing date- 2014-03-01.(b)(4).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 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: 5673675
• MDR Text Key: 45716252
• Report Number: 3007042319-2016-01993
• 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: 09/04/2015

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: 01/31/2015
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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-1917-2015
• Patient Sequence Number: 1