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

Catalog Number	1435
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cdc adapter 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 revealed that the device passed visual examination but failed functional testing due to an intermittent loose contact within the connector, the loose contact caused the loss of power from the cdc adapter.Per the instructions for use (ifu): information for use-the power supply connections are identical and are used to connect to any of the power sources (batteries, ac adapter or dc adapter).The controller should always be connected to two power sources for safety.Always keep a spare controller and fully charged spare batteries available at all times in case of an emergency.A green indicator light on the adapter will indicate proper connection.Ensure that the power indicator on the power adapter cable turns green before plugging into the controller.It further warns that damaged equipment should be reported to the manufacturer and inspected.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.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.
Event or Problem Description
It was reported that the patient's car dc adapter was not functioning.  this is not be likely to cause or contribute to death or serious injury.  the redundant power source will continue to supply power to the pump.  this failure will result in user annoyance and will not affect the function of the pump.The bac is not connected to the pump system and will not effect the functioning of the pump.  no consequence to patient.  no additional information available.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6828936
• Report Number: 3007042319-2017-02929
• Device Sequence Number: 41429
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/20/2016
• Device Catalogue Number: 1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR