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

Model Number	1650-
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: it was reported the battery caused a yellow light on the battery charger and was not recognized by the controller.Two batteries ((b)(4)) were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.The reported event was confirmed during bench testing.Failure analysis of the returned devices revealed that the units passed visual inspection but failed functional testing as a result of an inability of the batteries to charge or provide power.Supplemental testing revealed there was a communication error between the gas gauge integrated chip (ic) that monitors the batteries and reports information to the controller and the ic that measures cell pair voltages and provides safety protection when certain conditions are met.Additionally, supplemental testing of (b)(4) revealed that there was a memory corruption within the gas gauge integrated chip (ic).The communication error and memory corruption caused the batteries to trigger a safety flag and become inoperable, thus flashing yellow on the battery charger.As a result, the most likely root cause of the reported event can be attributed to a communication error between the gas gauge integrated circuit (ic) and the ic that measures cell pair voltages, as well as a memory corruption of the battery ((b)(4)), triggering safety flags that rendered the unit inoperable.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.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 ¿battery.Battery / (b)(4)/ model #: 1650 / expiration date: 2015-10-31, udi #: (b)(4).(b)(4).Return date: 2015-06-01, mfg date: 2014-10-31.(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the controller did not recognize the battery when it was connected.Additionally the battery caused a yellow light on the battery charger.Two batteries were exchanged.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-BATTERY
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7139653
• Report Number: 3007042319-2017-05375
• Device Sequence Number: 16411431
• Product Code: DSQ
• UDI-Device Identifier: 00888707000079
• UDI-Public: 00888707000079
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

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: 10/31/2015
• Device Model Number: 1650-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1