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

Catalog Number 1650

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the fully-charged indicator light would not illuminate while connected to the charger.The 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.A review of the device's incoming inspection records indicated there were no ncmrs generated that could be related to the reported event.Upon completion of the review, it was concluded that the unit met the internal requirements prior to its quality assurance release process.Failure analysis of the returned device revealed that the battery passed visual examination but failed functional testing due to an inability of the battery to charge and provide power to the controller for a period of 1 hour; however, led illuminated as intended.Internal inspection of the battery revealed that the red wire (thermistor ground) was loose and the annular ring (at e7) was broken which cause the voltage to drop to 0, this is an additional observation not related to the reported event.The most likely root cause of this observation can be attributed to a solder defect, resulting in a loose terminal.The reported event of defective led could not be confirmed or duplicated during failure analysis.The manufacturer has opened an investigation with the supplier to evaluate the display error.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 controller requires two power sources for safe operation: either two batteries, or one battery and an ac adapter or dc adapter.The instructions for use (ifu) and patient manual include a reference guide for both visual and tone alarms including potential causes and actions to take.They also 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 damages.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all times.The steps for exchange of batteries and controllers are outlined.The ifu further warns that damaged equipment should be reported to the manufacturer and inspected.

Event Description

A report was received that a patient noted that one of her batteries would not display the green, fully charged indicator light when placed in her battery charger.She reported that the same issue occurred with this battery when she placed it to charge in the other slots of the battery charger.The patient further reported that other batteries were correctly indicating a full charge when they were placed in the battery charger.The faulty battery's fuel gauge indicates four green bars but it is unclear if the battery is fully charged or has a capacity of 75-100%.The patient denied any damage to the battery and reported that there were no alarms associated with this event.The battery was exchanged with no reported patient consequence.Preliminary device analysis included findings of an unstable connection between the test controller and the battery.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM, BATTERY
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6515519
• MDR Text Key: 73511289
• Report Number: 3007042319-2017-01232
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000376
• UDI-Public: 010088870700037611160321
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 1650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 50