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

Catalog Number 1407DE

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2017

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 system.It sends power and operating signals to the blood pump and collects information from the pump.The hvad controller requires two power sources for safe operation.The instructions for use (ifu) and patient manual explain the correct method of connecting to and disconnecting from the power sources and the controller to prevent damage to either the power source connections or the controller power ports.The instructions for use and patient manual include a warning to keep a spare back up controller available at all times and outlines that if there is a controller failure, the controller should be switched to the back-up controller.The steps for exchange of devices are also outlined.It further warns that damaged equipment should be reported to the manufacturer and inspected.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.

Event Description

A report was received that power port 2 of the controller disconnected from the controller housing while the patient was performing a routine battery exchange.The controller sounded "power disconnect" alarm with message "power disconnect, connect power 2".The power port could be pulled out 2-3 centimeters from the housing.The patient was connected to another power source on port 1 at the time of the reported event.The controller was exchanged at the implanting center with no reported consequence or impact to the patient.The controller had not been dropped or sustained any damage.The event was not associated with a loss of power or pump stop.The user did not apply excessive force when connecting power sources.Pictures were sent.No further information was provided.

Manufacturer Narrative

After further review of additional information have been updated accordingly.It was reported that power port 2 of the controller was loose and a power disconnect alarm was heard.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.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned device revealed that the device failed visual inspection due to a loose power port 1 and 2.Internal inspection revealed that port 2 connector's washer and locknut were moving inside the controller allowing to migrate freely between the power board and main board.However, power port 2 was re-assembled and power up successfully indicating no short circuit caused inside.Additionally, the controller port 1 connector's locknut was loose inside the housing.The loose power port 1 is an additional observation not related to the reported event.The most likely root cause of the reported loose connector may be attributed to a shift in the manufacturing process.The manufacturer has an open internal investigation to evaluate the anomalies of loose connectors.Alarm file did not record any "power disconnect alarm" within the analyzed period as described in the reported event details.However, event file revealed a controller power up and motor start event on 01/18/2017 at 15:03:57 and 15:04:02 respectively.The data point prior to the loss of power revealed that (b)(4) was connected to power port 1 with 99% rsoc and (b)(4) was connected to power port 2 with 34%.The data point after the loss of power revealed that (b)(4) was connected to power port 1 with 97% rsoc and (b)(4) was connected to power port 2 with 96% rsoc.The loss of power with a no power alarm was most likely perceived by the patient as the reported "power disconnect alarm".The most likely root cause of the reported "power disconnect alarm" can be attributed to a disconnection of both power sources, given that power source 2 connected prior to the loss of power was replaced.  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, BATTERY
• 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: 6312425
• MDR Text Key: 66866689
• Report Number: 3007042319-2017-00380
• 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: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 1407DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• 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-0005-2017
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 72