MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER; VENTRICULAR (ASSISST) BYPASS

Model Number	1430US
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.Other devices involved in this event: heartware ventricular assist system ¿ controller ac adapter/ (b)(4)/ model #: 1430us / return date: 2018-09-10 device evaluation anticipated, but not yet begun (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that multiple controller ac adaptors would not provide power when connected to the controller.The multiple adaptors were exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.Failure analysis of the returned controller revealed bent pins within power port one (1) of the controller.The bent pins did not allow a battery to properly connect to the controller.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to a misalignment between the power port and battery output connector.In internal investigation was opened to investigate bent/damaged pins with controller 2.0.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER AC ADAPTER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7866388
• Report Number: 3007042319-2018-04357
• Device Sequence Number: 19258255
• Product Code: DSQ
• UDI-Device Identifier: 00888707002738
• UDI-Public: 00888707002738
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 01/19/2019
• Device Model Number: 1430US
• Device Catalogue Number: 1430US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1538-2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCS VAD
• Patient Age: 37 YR