MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER; 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	12/29/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 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 of the device revealed that the device failed to meet specifications; the device passed visual examination but failed functional testing due to a lack of output voltage.Closer inspection with a dmm revealed an intermittent lack of continuity in the power (red) wire within the connector.The confirmed malfunction is related to the reported event.The most likely root cause of the reported event can be attributed to mishandling of the cdc adapter cable.The instructions for use (ifu) and patient manual include a reference guide for visual alarms including potential causes and actions to take.Additionally there is a warning to keep spare, fully charged batteries available at all time.The steps for exchange of batteries are outlined.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 pt seen in clinic on (b)(6) 2015 reporting that dc adapter was no longer providing power to controller.The adaptor was replaced.There was no impact to the patient.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER DC ADAPTER
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 6937881
• Report Number: 3007042319-2017-03664
• Device Sequence Number: 16446419
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/06/2016

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: 07/30/2015
• Device Catalogue Number: 1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• 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: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 83