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

Catalog Number	1650
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2015
Type of Reportable Event	Serious Injury
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 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.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.One battery 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.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.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 two cables that were found with the pcb via damaged from the pcb, causing them to make an intermittent connection with the pcb.The confirmed malfunction is related to the reported event.An internal investigation has been opened to evaluate these types of issues.The most likely root cause of the failure is improper assembly, which likely contributed to the event.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
Event or Problem Description
It was reported that the patient states that when he hooks this battery up to a charger, the charger will display a flashing yellow light and this occurs in multiple slots.The battery was taken out of service.There was no impact to the patient.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60 avenue; miami lakes FL 33014 3105
• MDR Report Key: 5489106
• Report Number: 3007042319-2016-01078
• Device Sequence Number: 13564345
• Product Code: DSQ
• UDI-Device Identifier: 00888707000079
• UDI-Public: 010088870700007915020521BAT122102
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/20/2015

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: 02/29/2016
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2016
• Initial Report FDA Received Date: 03/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1