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

Catalog Number	1435
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cdc adapter was not returned for analysis.Review of the manufacturing records confirmed that the associated device met all requirements for release.The reported event could not be confirmed.Analysis could not be performed as the device was not returned.Per the instructions for use (ifu): 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.The hvad controller requires two power sources for safety: either two batteries or one battery and an ac adapter or dc adapter.The dc adapter plugs into the power port located in most cars.When the dc adapter is properly connected to power, a green indicator light will be displayed on the adapter.If the ac/dc indicator doesn't turn green, the controller is using battery power and the "power disconnect" alarm will sound.The ifu cautions users to not force connectors together without proper alignment.Forcing together misaligned connectors may damage the connectors.Users are instructed to return any damaged components to the manufacturer.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
A report was received from the clinical database that the patient had issues with the cdc adapter remaining connected to the controller.The cdc adapter no longer connects at all.The cdc adapter was replaced with no reported patient consequence.The event resolved with the replacement device.The controller power connectors were reportedly not damaged.The site was unable to provide information about whether the connectors of the cdc adapter were damaged.There was a battery connected to the opposing power port of the controller at the time of the reported event.The event was not associated with any controller alarms or pump stops.No further information has been provided.

• 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: 6786905
• Report Number: 3007042319-2017-02595
• Device Sequence Number: 1540843
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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 Catalogue Number: 1435
• Was Device Available for Evaluation?: No
• 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: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 79