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

Model Number 1650-

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: it was reported that the patient experienced a critical battery alarm with a fully charged battery.Three batteries 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.Failure analysis of the returned batteries revealed that the devices passed visual inspection and functional testing.Log file analysis was not conducted since log files covering the event date were not available.As a result, the reported event could not be confirmed.Applicable risk documentation and experience with events of similar circumstances were considered; events with critical battery alarms, are most often attributed to communication errors between the controller and batteries.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.Additional products: battery (b)(4) expiration date: 2016-01-31, udi#: n/a, return date: 2015-10-26, evaluated by mfr, mfg date: 2015-01-31.Battery (b)(4), expiration date: 2015-07-31, udi#: n/a, return date: 2015-10-26, evaluated by mfr, mfg date: 2014-07-31.

Event Description

It was reported that the controller displayed a critical battery alarm on a fully charged battery.It was also stated that two other new batteries received a low battery alarm.The three batteries were replaced.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7154787
• MDR Text Key: 96614485
• Report Number: 3007042319-2017-05516
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2016
• Device Model Number: 1650-
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR