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

Catalog Number	1425US
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cac 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 open connection within one of the wires of the cable at the connector's side.The most likely root cause of the reported event can be attributed to wear on the strain relief as a result of excessive bending.The usage pattern most likely contributed to the fraying or breaking of the cable wire.Per the instructions for use (ifu): the hvad controller requires two power sources for safe operation: either two batteries, or one battery and an ac adapter or dc adapter.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 cac adapter has cables that connect to the controller and into an electrical outlet.The instructions for use (ifu) and patient manual instruct the user that a green indicator light on the adapter will indicate proper connection.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 patient reported that his/her cac adapter was alarming and beeping at night and intermittently shutting off. this was associated with no reported patient issue or injury. the patient is noted to need a new cac adapter.

• 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: 6819019
• Report Number: 3007042319-2017-02838
• Device Sequence Number: 16183630
• Product Code: DSQ
• UDI-Device Identifier: 00888707000093
• UDI-Public: 00888707000093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/01/2016

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: 09/30/2014
• Device Catalogue Number: 1425US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2016
• 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: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 81