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

Catalog Number	1650
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2016
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 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 and patient manual outline the steps for handling and properly connecting power sources, including ensuring proper alignment, as well as instructions not to twist or force connections together in order to prevent damage.Additionally, a reference guide for both visual and tone alarms including potential causes and actions to take and there is a warning to keep spare, fully charged batteries and back up controller available at all times.It also provides information about proper care of the system and what to do in case of an emergency.Always wait until the "ready" turns on to disconnect the battery from the battery charger.The reported inoperability of the returned battery, (b)(4), was confirmed.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.Analysis of the device revealed that the device failed to meet specifications; the device passed visual examination but failed functional testing as it was completely inoperable as received.Internal visual inspection revealed an improper weld on cell pack 3 which caused an intermittent connection.Heartware has opened an internal investigation to evaluate battery cell and battery construction failures.The most likely root cause of the reported event can be attributed to improper assembly.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
During testing and investigation it was found that the battery failed functional testing due a faulty weld on cell pack #3.͊.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Common Device Name: CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 5896400
• Report Number: 3007042319-2016-02943
• Device Sequence Number: 330068
• Product Code: DSQ
• UDI-Device Identifier: 00888707000079
• UDI-Public: 010088870700007911141216
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/04/2016

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: 12/31/2015
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2016
• Initial Report FDA Received Date: 08/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1