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 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that no 4th green light was observed when fully charged.The battery was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the device in relation to the reported event.Results of the analysis revealed that the battery had a permanent failure flag enabled that rendered the battery inoperable.Failure analysis of the returned device revealed that the device passed visual examination but failed functional testing due to that battery was not able to communicate with either the controller or the battery charger, causing the patient to perceive a defective led.The most likely root of cause of the reported event is due to an incorrect write/verify data into the u2 bq20z80 chip flash memory which enabled the failure flag that rendered the battery pack inoperable.The most likely root cause of the reported event can be attributed to a memory corruption of the battery, triggering safety flags that rendered the unit inoperable.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 both visual and tone alarms including potential causes and actions to take.Additionally there is a warning to keep spare, fully charged batteries and back up controller available at all time.The steps for exchange of batteries and controllers are outlined.

Event Description

It was reported by the vad coordinator that the 4th green light on the battery does not illuminate when fully charged.The battery was replaced.There was no impact to the patient.Preliminary analysis of the device revealed possible communication between the battery and the controller.

• 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: 6497595
• MDR Text Key: 72937953
• Report Number: 3007042319-2017-01154
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000376
• UDI-Public: 010088870700037611160315
• 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: Other
• Type of Report: Initial
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• 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: 03/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/15/2016
• 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: 65 YR